In the United States (U.S.), cancer-related age-adjusted mortality rates significantly declined from 206 deaths per 100,000 persons (1995-1999) to 155 deaths per 100,000 persons (2014-2018). This encouraging trend is likely related to the sharp increase in approvals of oncology therapies by the U.S. Food and Drug Administration (FDA). More than any other therapeutic area, oncology trials and cancer research saw a greater number of fast track, accelerated, and priority approvals between 2000 and 2017. Of the 300 drugs approved by the U.S. FDA over the last 30 years, nearly 35% were from oncology clinical trials, reflecting the continuous need for new and novel therapeutics in cancer care.

During this same 30-year period, especially in the last few years, the reliance on oncology contract research organizations (CROs) has gradually expanded to all phases of cancer clinical trials. When collaborating with a high-quality CRO partner, cancer research sponsors can benefit from improved data reliability and integrity, in addition to consistently meeting rigorous industry and protocol compliance standards. However, some CROs stand out above others, particularly in the field of oncology where successful clinical trials must overcome several unique challenges.

In this article, we will discover the top five leading oncology-focused CROs for 2025, presented in no particular order. Continue reading to learn how these top specialty CROs are advancing cancer research with innovative trial designs, specialized expertise, and cutting-edge technology.

1. Medelis Oncology CRO

Founded: 2003

Headquarters: Thompson Station, Tennessee

Oncology is one of the major areas of focus for Medelis, a specialty CRO that conducts Phase I through Phase III cancer research trials, but it also provides expertise in other therapeutic areas, including nephrology, neurology, medical devices, and dental research. Being a niche oncology CRO, Medelis offers sponsors the unique benefit of their deep operational expertise, offered by their highly skilled and proactive clinical trial management team. Led by their group of experienced clinical research oncologists, this CRO has been a pioneer in immunotherapy studies since 2008, running numerous CAR T-cell therapy studies, checkpoint inhibitor studies, and bispecific antibody treatment studies. Among their services are study design assistance, strategic site selection, providing access to the right patient populations, and up-to-date regulatory guidance per the FDA, European Medicines Agency, and other agencies.

Notable News: As a smaller specialized CRO, Medelis is able to take a personalized approach that prioritizes each sponsor’s unique needs. The company has been brought on to rescue multiple cancer clinical trials and successfully delivered improved timelines, data quality, and increased enrollment rates. Whether it’s a standard dose-escalation Phase I trial or a complex rescue of a Phase III study, Medelis Oncology CRO boasts 91% of their projects are completed on time and 96% remain within budget.

2. Theradex Oncology CRO

Founded: 1982

Headquarters: Princeton, New Jersey

Next on our list of top CROs for oncology in 2025 is Theradex, a global mid-sized CRO that was founded upon being awarded the Clinical Trials Monitoring Service contract in 1982 for the U.S. National Cancer Institute (NCI). Originally, the company began with providing central data management and monitoring services for early phase oncology trials sponsored by the NCI. In 2014, this role expanded to lend additional support to clinical trials conducted under the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). Today, Theradex’s services have extended to pharmaceutical industry sponsored oncology trials across the U.S., Europe, Asia, and Australia. As a mid-size company, this CRO has been able to grow their global footprint significantly while still maintaining a tailored approach to study management for each industry sponsor they partner with. Overall, Medelis has amassed over 40 years of experience in conducting quality oncology trials spanning a diverse range of cancers, including but not limited to, lung, breast, colorectal, and hematologic malignancies.

Notable News: In November 2022, Theradex Oncology CRO was appointed by Shuttle Pharmaceuticals to prepare for its Phase II clinical trial of ropidoxuridine to treat glioblastoma, a brain tumor. Specifically, they collaborated with Shuttle and the U.S. FDA to prepare the Investigational New Drug (IND) application for this trial. As of October 2024, the ropidoxuridine clinical trial has completed its clinical trial site enrollment and has begun enrolling patients with aggressive, IDH wild-type, methylation negative glioblastomas.

3. TFS HealthScience CRO

Founding Year: 1996

Company HQ Location: Lund, Sweden

4. Allucent Oncology & Hematology CRO

Founded: 1988

Headquarters: North Carolina (U.S.); Berkshire (United Kingdom); Schiphol (The Netherlands)

Since 1988, several life science CROs have undergone mergers while serving the specialized needs of small and mid-sized biotechs, leading to the company’s rebranding as Allucent in 2022. Over the last 30 years, this mid-sized CRO has amassed significant expertise in regulatory trends, therapeutic experience, and operational expertise in the field of oncology. Although, they also offer services for other therapeutic areas such as infectious disease and vaccines, autoimmune and inflammation, cell and gene therapy, and rare diseases. Today, the company’s global footprint spans over 75 years across North America, Europe, and the Middle East, with oncology trials making up the majority of its portfolio of over 825 clinical trials. The Allucent Oncology & Hematology unit supports its sponsors through every phase of drug development, from preclinical planning and IND submissions to the design and execution of Phase I-III clinical trials, including marketing applications, and Phase IV and post-marketing initiatives.

Notable News: In May 2024, Allucent was recognized with two CRO leadership awards presented by Clinical Leader and Life Science Connect in the Expertise and Compatibility categories across Small Pharma and Overall (Big and Small Pharma combined), respectively. Earlier this July, Allucent was also selected by the Biomedical Advanced Research and Development Authority (BARDA) for its new Decentralized Clinical Operations for Healthcare and Research (D-COHRe) initiative. This agreement was created for the U.S. Department of Health and Human Services to improve the nation’s ability to respond to future public health emergencies.

5. Ergomed Oncology CRO

Founded: 1997

Headquarters: Surrey, United Kingdom

Since 1997, Ergomed has grown into a leading global mid-sized oncology CRO with a strong presence across North America, Europe, and the APAC region today. Their wide array of comprehensive services, including clinical development, trial management, and pharmacovigilance support, have been relied on by more than 300 sponsors across 100 countries worldwide. Ergomed does offer expertise in multiple therapeutic areas (e.g., rare disease, neurology, etc.), but 32% of Ergomed’s entire clinical trial portfolio falls within cancer research, particularly for early-phase oncology trials, encompassing over 470 cancer projects that have enrolled more than 32,000 patients. Sponsors can also take advantage of this CRO’s long-standing track record with successful cell and gene therapy clinical trials, collaborative trial management processes, and comprehensive support for recruitment, logistics, and medical initiatives tailored to each investigative site. Ergomed’s accomplishments and strong background in oncology trials place it among the top CROs for oncology in 2025.

Notable News: In October 2024, Ergomed announced its CRO partnership with CEL-SCI Corporation for the upcoming U.S. FDA confirmatory Registration Study of Multikine^® (Leukocyte Interleukin, Injection) in head and neck cancer. As their oncology CRO , Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of this study, building on their previous partnership for the Phase 3 trial of Multikine^®, the largest study ever conducted in head and neck cancer.

Conclusion

As we approach 2025, these five leading specialty oncology CROs demonstrate the evolving landscape of cancer research. Medelis, Theradex, TFS, Allucent, and Ergomed each offer industry sponsors a unique blend of expertise and successful track record to help advance cancer treatment options and improve patient outcomes worldwide. For pharmaceutical and biotech companies seeking to conduct successful oncology trials, these CROs represent some of the most experienced and capable partners in the industry to watch in 2025!

TFS: Your Trusted Oncology CRO Partner

TFS HealthScience Oncology and Hematology CRO is dedicated to providing comprehensive services to support your oncology clinical trials. With a proven track record of over 300 cancer-related clinical trials across all phases, we’re committed to delivering solutions that match your needs. Our global operations teams are fully experienced with navigating the complex landscape of cancer clinical research, offering rigorous operational oversight and adherence to global standards. Visit our oncology CRO website to learn more or connect with a TFS representative here!

Interested in more Oncology and Hematology CRO content from TFS? Visit our Intellect Hub here to access white papers, articles, case studies, and more!

In February 2024, the IQVIA Institute for Human Data Science released their annual report here on global trends in clinical trials Research and Development (R&D) for 2024. The report highlighted several exciting developments driving innovation and progress within the pharmaceutical clinical research industry, from predictive biomarkers to technology-enabled digital and decentralized trial designs. This has been made possible largely with the growing reliance of industry sponsors on partnerships with contract research organizations (CROs), which are specialized providers that are outsourced on a contractual basis by pharmaceutical, biotechnology, and medical device companies. In North America alone, the pharmaceutical CRO market is expected to reach a projected revenue of $13.73 billion by 2030, with a compound annual growth rate (CAGR) of 5.6% between 2025 and 2030.

As we approach the new year, the clinical research industry is poised for rapid growth and significant advancements, with CROs at the forefront of these changes. This article highlights the top 10 CROs that are expected to make waves in 2025, in no particular order, showcasing their unique strengths, innovative approaches, and potential impact on the future of drug development. Continue reading as we dive into the profiles of these industry leaders and explore how they’re positioned to influence the pharmaceutical clinical trials landscape in 2025 and beyond.

1. Medpace Holdings Inc.

Founding Year: 1992

Company HQ Location: Ohio, United States

Medpace stands out as a top CRO to watch for in 2025 due to its unique strengths and strategic positioning in the clinical trials industry. The company’s mission is to help biotech and biopharma companies accelerate the development of their medical therapeutics, offering a full breadth of clinical services and a collaborative approach across several areas of expertise. As a full-service global CRO, Medpace provides continuous insights from their medical experts across all major areas, including oncology, cardiology, metabolic disease, as well as crossovers such as rare diseases, cell and gene therapy, women’s health, and more. Partnering with Medpace CRO also lends sponsors access to a variety of their integrated central and bioanalytical laboratory services, the Medpace Core Lab for imaging and safety services, and even a Phase I unit with solutions for navigating early-phase clinical trials.

Notable Milestones: In 2022, Medpace invested a capital of $150 million into expanding its headquarters in Cincinnati, Ohio. The company has also been recognized with multiple industry awards, from being named a 2021 SCRS Eagle Award finalist to ranking among Forbes America’s Best Mid-size Companies in 2021. In 2023, Medpace received 5 CRO Leadership Awards for reliability, quality, expertise, compatibility, and capabilities.

2. TFS HealthScience CRO

Founding Year: 1996

Company HQ Location: Lund, Sweden

3. PPD, a Subsidiary of Thermo Fisher Scientific

Founding Year: 1985

Company HQ Location: North Carolina, United States

PPD has been a leader within the pharmaceutical and CRO industries, delivering consistent and reliable research services in over 100 countries. In December 2021, PPD became a wholly owned subsidiary of Thermo Fisher Scientific, operating under their clinical research business as a high-quality provider of end-to-end drug development and study design capabilities. From early development through regulatory approval and market access, PPD offers local and global experts across more than 20 key therapeutic areas, including oncology and hematology, infectious diseases, dermatology, and critical care. For over 40 years, their combined clinical development and laboratory services have helped streamline the complex drug development process for sponsors, enabling faster and more informed decisions about investigational products without compromising safety and efficacy.

Notable Milestones: In September 2024, PPD and Thermo Fisher Scientific launched the international CorEvitas Adolescent Atopic Dermatitis (AD) Registry to promote novel therapeutic development for AD, the most common inflammatory skin condition in adolescent patients. The company also announced in October 2024 a collaboration with DHL Express’ GoGreen Plus service to invest in sustainable aviation fuel (SAF) to reduce emissions from air transportation within the PPD clinical research business.

4. Premier Research

Founding Year: 1989

Company HQ Location: North Carolina, United States

Premier Research is a mid-sized CRO made up of therapeutically focused teams of clinical professionals who have the knowledge and experience necessary to effectively manage complex clinical trials in all major areas. This CRO’s expertise spans oncology and hematology, rare disease, cell and gene therapy, analgesia, dermatology, women’s health, internal medicine and immunology, MedTech, and more. Beyond their clinical development offerings, Premier provides sponsors access to product development and regulatory consulting, nonclinical and early development services, Functional Service Provider (FSP) models, and real-world and late phase study capabilities. With over 35 years of experience in the pharmaceutical industry, Premier Research consistently leverages the latest technology and therapeutic expertise to deliver faster development timelines, access to the right patients, and globally compliant clinical trials.

Notable Milestones: In October 2024, Premier Research announced the first patient dosed in their first-in-class INVISE (Injectable Vectors for In Situ Engineering) clinical trial in partnership with Interius BioTherapeutics. INVISE is a Phase I study that is evaluating the safety of a single INT2104 infusion in adults with refractory/relapsing B cell malignancies, as the first human clinical trial of an in vivo Chimeric Antigen Receptor (CAR) gene therapy.

5. Charles River Laboratories International Inc.

Founding Year: 1947

Company HQ Location: Massachusetts, United States

Charles River Laboratories is a leading full-service global CRO that specializes in preclinical research, drug discovery, and development services. In addition to its preclinical and clinical laboratory, gene therapy, and cell therapy capabilities, Charles River also specializes in cell sourcing, regulatory advisory consulting, and contract development and manufacturing (CDMO) services, among others. For over 75 years, the company’s industry-experienced, multidisciplinary teams have maintained a successful track record of supporting scientific clients from basic research, discovery, and safety assessment, to manufacturing and commercialization. As of 2024, Charles River had over 150 facilities, operating in 21 countries with over 21,000 people employed worldwide. Their global footprint also encompasses over 80% of all drugs approved by the United States (U.S.) Food and Drug Administration (FDA) in the last five years.

Notable Milestones: Earlier this year, Charles River announced strategic CDMO manufacturing collaborations with organizations including FOXG1 Research Foundation and AAVantgarde, dedicated to providing therapeutic treatments for rare disease patients. They are also providing comprehensive adeno-associated virus (AAV) gene therapy manufacturing collaboration to support early phase trials in the Asia-Pacific (APAC) region.

6. IQVIA

Founding Year: 1982

Company HQ Location: Connecticut, United States

IQVIA is one of the largest and most experienced CROs in the world, with a global network of over 85,000 employees in more than 100 countries and long-standing expertise across 17 major therapeutic areas. For nearly 45 years, this global CRO has been transforming clinical research, supporting therapeutic breakthroughs, and helping expedite new therapies for conditions in oncology, dermatology, nephrology, pediatrics, rheumatology, and many more. The company also offers a variety of technological innovations, including IQVIA Connected Intelligence^TM, IQVIA Healthcare-grade AI^TM (Artificial Intelligence), IQVIA AI Assistant, and Human Data Science Cloud. IQVIA-powered trials also benefit from this CRO’s patient experience solutions which are integrated with Apple devices for greater personalization of healthcare delivery.

Notable Milestones: This September, Frost & Sullivan, a leading independent research and consulting firm, awarded IQVIA with the 2024 Global Customer Value Leadership Award for excellence in the global AI quality and regulatory solutions space for the healthcare industry. Similar to all IQVIA AI-powered solutions, IQVIA’s SmartSolve’s eQMS platform is grounded in IQVIA Healthcare-grade AI. The following month, the CRO also announced its IQVIA AI Assistant, a user-friendly, conversational text interface that allows customers to ask complex questions about their business and receive fast, comprehensive, and reliable answers.

7. Worldwide Clinical Trials Inc.

Founding Year: 1986

Company HQ Location: North Carolina, United States

Worldwide Clinical Trials is a leading full-service global CRO that creates customized strategies to support biotech and biopharma companies in clinical drug development. This mid-size CRO’s solutions span bioanalytical laboratory services, Phase I to Phase IV clinical trials, rescue study support, as well as post-approval and real-world evidence (RWE) studies. Worldwide’s therapeutic expertise consists of five key areas: cardiovascular and metabolic diseases, oncology, neuroscience, rare disease, cell and gene therapy, and immune-mediated inflammatory diseases. Across each of these therapeutic areas, sponsors can take advantage of Worldwide’s cross-functional teams specializing in a variety of capabilities, from trial optimization and protocol development to consulting and global regulatory guidance, among others.

Notable Milestones: In November, Worldwide Clinical Trials was named a finalist in Fierce Healthcare’s 2024 Fierce Diversity, Equity, and Inclusion (DEI) Awards in the category of Innovative Education and Training. In May 2023, the CRO also announced a partnership with the data-based non-profit organization, Every Cure, to accelerate the discovery of treatments for rare disease patients. In this collaboration, Worldwide will use its clinical development and rare disease expertise to assist in identifying links between rare diseases and generic drugs on the market using Every Cure’s open-source database of drug-repurposing opportunities.

8. ICON plc

Founding Year: 1990

Company HQ Location: Dublin, Ireland

Over the last 35 years, ICON has become a renowned leading global CRO provider of outsourced development services to the pharmaceutical industry, with over 42,000 professionals employed worldwide. The company has a vast geographic footprint, operating out of 106 locations across 55 countries and delivering its comprehensive clinical trials support services in 93 countries worldwide. ICON CRO offers a broad range of specialized clinical, consulting, and commercial solutions to ensure sponsors across various industry sectors meet the full potential of their clinical trials. These include central laboratory services, medical imaging capabilities, decentralized clinical trial support, real-world intelligence, site and patient solutions, and several more. ICON’s services are built to handle complex studies across several therapeutic and cross-therapeutic areas, from cardiovascular and infectious diseases to medical devices and the development of biosimilars/vaccines. With these capabilities and more, ICON is one of the top CROs to watch in 2025.

Notable Milestones: In July 2024, ICON was recognized for its excellence in clinical research in all categories at the CRO Leadership Awards 2024. They also received Individual Attribute Awards in the areas of data quality, meeting project timelines, operational excellence, technology for access to data, and therapeutic expertise. In the technology sector, ICON’s AI solution, Cassandra, won for Excellence in Use of Real-World Data/Evidence at the Citeline 2024 awards, which are held to recognize excellence in clinical trial design and technological advancements. Additionally, ICON’s site network, Accellacare, was named Best Clinical Trial Network at the 2024 Vaccine Industry Excellence Awards.

9. Fortrea Holdings, Inc.

Founding Year: 1978

Company HQ Location: North Carolina, United States

Another top CRO to watch in 2024 is Fortrea, a subsidiary of Labcorp’s (formerly known as Covance) Clinical Development business. Fortrea is a leading global life sciences CRO that provides comprehensive drug and medical device development services across Phase I-IV clinical trials to empower patients and providers. With their team of 19,000 clinical professionals, Fortrea provides sponsors access to a wide array of services including bioanalytical testing, data management, biostatistical analysis, and more. This CRO supports several stakeholders, from patients and physicians to health organizations and biopharma clients. For sponsors, Fortrea also offers robust capabilities in clinical trial management, central lab services, and commercialization services, which ensure their clinical trials generate accurate, reliable results in accordance with rigorous regulatory and data privacy standards. With these comprehensive services, Fortrea supported 84% of all new drugs and therapeutic products approved in 2023 by the FDA.

Notable Milestones: In November 2024, Fortrea launched new enhancements to Global Trial Connect, the company’s suite of digital, data and operational solutions for clinical trials and investigative sites. These updates improved site workflow facilitation and integrated sample collection with data tracking to promote earlier decision-making with actionable analytics that help both sites and sponsors reduce queries. In October, they also announced the availability of the VENTANA® CLDN18 (43-14A) RxDx Assay in the U.S., the first companion diagnostic assay to identify patients with gastric cancer who may be eligible for treatment with VYLOY.

10. Syneos Health^®

Founding Year: 1998

Company HQ Location: North Carolina, United States

Last, but not least, Syneos Health^® is the final company on our list of top 10 CROs to watch in 2025. Syneos is a widely recognized global CRO with operations in over 110 countries worldwide. This leading biopharmaceutical solutions organization’s mission is to translate unique clinical, medical affairs and commercial insights into outcomes that address modern market realities in the clinical research industry. Their offered solutions include clinical development, medical affairs, commercial delivery, and consulting services, which span 16 therapeutic areas, including dermatology, endocrinology, neuroscience, women’s health, medical device and diagnostics, respiratory, and several others. Syneos is also a technologically forward CRO that provides its clients with access to innovative platforms such as StudyKik (Patient Recruitment for Clinical Trials), Kinetic (Healthcare Business Intelligence Platform), AnswerSuite (Biopharmaceutical Syndicated Data Platform), RxDataScience (Biopharma Analytics Platform), and more. With a tech-enabled problem-solving approach, sponsors benefit from this CRO’s ability to navigate real-world challenges using customized technology solutions for streamlined clinical trials.

Notable Milestones: In June 2024, Syneos Health was recognized on the Forbes list of America’s Best Management Consulting Firms 2024 for their commitment to delivering high-value customer solutions. In 2023, the CRO also expanded its strategic collaboration with Oracle to leverage the Oracle Cerner Learning Health Network (LHN) and elements of Oracle’s suite of study startup solutions to improve patient recruitment timelines and help close diversity gaps in patient recruitment.

Conclusion

In conclusion, these are the top 10 CROs at the forefront of the clinical research industry and its rapidly evolving drug development landscape. From pioneering AI-driven solutions to supporting novel therapeutic discovery in high-demand disease areas, each of these organizations will help shape clinical trial advancements in 2025. With their unique blend of technological innovation, strategic partnerships, and therapeutic expertise, these 10 CROs are poised to help deliver significant improvements to patient outcomes and drug development processes.

Interested in learning more about what a CRO does to support sponsors? Read more here.

About TFS HealthScience CRO

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. As a trusted mid-sized CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients.

Visit our website to learn more about the proactive solutions TFS can offer for your next clinical trial or connect with a TFS representative today!

Historically, quality assurance in clinical trials has always been a moving target, with the landscape of regulations and guidance changing on a continuous basis over the years. During this time, clinical trials have become increasingly complex, causing sponsors and contract research organizations (CROs) to face new challenges when balancing regulatory compliance needs with patient-centered practices that ensure patient safety. Recognizing this, the Chartered Quality Institute (CQI) and its International Register of Certified Auditors (IRCA) have set the theme for this year’s annual World Quality Week (November 11-15) to focus on the challenges of managing dynamic risk landscapes while navigating the growing complexity associated with clinical trial globalization.  

In this rapidly evolving industry, maintaining appropriate quality assurance can make or break the success of a study. Yet, the concept of quality in clinical trials is often misunderstood and can lead to inefficiencies, delays, and even compromised patient safety. In support of the CQI/IRCA’s global campaign to raise awareness of the quality management profession, this blog post aims to challenge these misconceptions head-on, offering a fresh perspective on what true quality means in the context of clinical research.  

Read on as we navigate ten prevalent beliefs about quality assurance in clinical trials and discover whether they are fact or fiction! 

1. Fact or Fiction: Compliance Equals Quality

Fiction: While compliance with protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and regulatory standards is crucial, it is a common misconception that compliance alone guarantees quality in clinical trials. In truth, compliance only establishes the baseline for conducting trials ethically and safely, whereas true quality in clinical research extends far beyond regulatory compliance. In today’s clinical trial landscape, sponsors and CROs must adopt a holistic approach to quality monitoring by implementing additional strategies involving continuous improvement, proactive risk management (e.g., risk-based monitoring), and a company culture that values scientific integrity and patient safety above all. Therefore, while compliance is necessary, making it the sole focus of quality assurance efforts runs the risk of researchers overlooking other critical aspects of trial quality that could be impacting the validity and reliability of a study.  

2. Fact or Fiction: Quality Assurance Can Prevent Delays in Clinical Trials

Fact: Strict quality assurance can indeed prevent delays in clinical trial project management. By conducting thorough quality checks at the outset and throughout the drug development process, research teams can catch and address any inconsistencies, errors, or compliance issues that might have otherwise led to costly setbacks that require time-consuming corrections later on. In a 2023 analysis conducted by the Tufts Center for the Study of Drug Development, the estimated direct daily cost to conduct a clinical trial is approximately $40,000 per day for phase II and phase III clinical trials. In fact, they found that even one day of delay translated to approximately $500,000 in lost prescription drug or biologic sales for pharmaceutical sponsors. To avoid these costly consequences, proactively identifying and implementing quality measures early in a study’s lifecycle can be an effective strategy for sponsors and their CRO partner to keep projects on track and ensure smoother timelines.  

3. Fact or Fiction: All CROs Maintain the Same Quality Standards

Fiction: The idea that all CROs adhere to identical quality assurance and quality control standards is actually a common misconception in the clinical trial industry. Of course, maintaining regulatory compliance is a fundamental requirement for all CRO partners in a study, but the reality is that each organization will vary in their quality standards, such as in their quality culture, investment in staff training and development, and commitment to continuous improvement processes. As seen in any industry, some CROs stand out more than others because they have a reliable track record of going above and beyond basic regulatory compliance and quality assurance methods.  

Industry leaders in quality typically take initiative by implementing efficient quality management systems (QMS), intentionally fostering a culture of sustainability and excellence, and consistently looking for ways to improve their approach. Differences in quality standards can significantly impact a study’s outcomes and overall success, as well as influence patient safety. Therefore, sponsors must consider a CRO’s quality practices and history in order to select the right partner for their clinical trial.  

4. Fact or Fiction: The Clinical Trials Industry Has Always Prioritized Patient Safety

Fiction: Contrary to popular belief, patient safety was not always the primary focus in clinical trials. Unfortunately, there were significant gaps in drug safety protocols that remained hidden until events like the thalidomide tragedy in the 1960s exposed them. Between the late 1950s and early 1960s, thalidomide was used across 46 countries to treat morning sickness in pregnant women. However, the lack of comprehensive safety testing on the reproductive toxicity effects of thalidomide resulted in more than 10,000 children being born with a range of severe physical deformities, as well as thousands of miscarriages taking place.  

This incident led to a global overhaul of clinical trial regulations, bringing patient safety and informed consent to the forefront. Specifically, the thalidomide disaster and its subsequent withdrawal from the market was a turning point in toxicity testing, as it prompted United States (U.S.) and international regulatory agencies to develop more robust toxicity testing protocols. This case offers crucial lessons about the importance of quality standards in clinical research that are still just as important today. This incident also underscores the need for strict global clinical research regulations that prioritize patient safety and thorough trial oversight. Accordingly, the World Health Organization recently launched its landmark publication “Guidance for best practices for clinical trials” in September 2024. Read more about this latest foundational resource in clinical trial quality here. 

5. Fact or Fiction: Risk-Based Monitoring (RBM) is an Efficient Quality Measure

Fact: RBM, or risk-based quality management (RBQM), is a powerful quality assurance measure for efficiently ensuring patient safety and data integrity in clinical trials. Whereas traditional monitoring involves exhaustive oversight over all trial sites and data, RBM allows for a more targeted approach by prioritizing only high-risk areas for error. For example, certain therapeutic areas such as oncology may be more prone to protocol deviations or certain sites may have a track record of frequent data errors. In response to these areas that require additional attention, RBM enables tailored solutions to be implemented proactively and continues to monitor risk throughout the trial in real-time. Since 2019, the use of RBM as a quality measure in clinical trials has increased from 53% to 88% as of 2021. This is likely because, unlike with a one-size-fits-all approach, sponsors and CROs can optimize their resource allocations more effectively with RBM, while still reaping significant benefits in quality improvements.  

6. Fact or Fiction: Quality is the Sole Responsibility of the Quality Assurance Team

Fiction: Quality is a shared responsibility that extends to every individual involved in the clinical trial process. Naturally, the quality assurance team plays a central role in the oversight and compliance with the required standards, but true excellence in quality can only be achieved with the collective efforts of all team members. Every stakeholder in a clinical trial is able to contribute to maintaining high standards in data integrity and patient safety: 

• Principal investigators (PIs) ensure overall protocol adherence and accurate data collection across their clinical research sites. 
• Clinical research coordinators (CRCs) maintain meticulous records of clinical trial data and patient care tasks.  
• Data managers are responsible for overseeing and safeguarding data integrity at all times.  
• Clinical research associates (CRAs) carry out RBM and source data verification (SDV) to ensure accuracy and consistency in a site’s data records.  
• Lab technicians follow precise technical procedures for biological sample handling and analysis. 

This collaborative approach to quality not only enhances the reliability and validity of trial results, but it also fosters a culture of excellence in quality assurance throughout the entire organization.  

7. Fact or Fiction: More Quality Assurance Checks Mean Better Quality

Fiction: Contrary to popular belief, increasing the number of quality assurance checks does not necessarily lead to better quality in clinical trials. This misconception stems from the idea that more oversight equates to higher standards, but quality actually entails implementing smart, targeted checks rather than overwhelming the process with excessive controls. The concept of quality over quantity in this case relates to the use of RBM in assessing and addressing potential issues in clinical trials.  

RBM has steadily grown in its support within the clinical trial industry. In June 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance, calling for greater support of RBM principles throughout clinical trial planning and execution. For more than a decade, the use of RBM has also been encouraged via Quality by Design principles and the ICH GCP E6 (R2) guidelines. The risk-based approach strategically allows sponsors and their CRO partners to divert resources toward high-impact areas, rather than spreading them thin across the board. The goal is to collect the right data, not necessarily more data.  

Sponsors and CROs can adopt several key strategies for smart quality assurance checks that do not overburden staff with excessive oversight: 

• Focus on high-priority data points that directly impact patient safety and study outcomes. 
• Leverage advanced analytics (including artificial intelligence [AI] input) to identify data patterns and potential issues. 
• Promote a supportive culture of regulatory compliance, quality, and transparency throughout every level of the company.  

8. Fact or Fiction: EDC Transformed Data Quality in the 1990s

Fact: Electronic Data Capture (EDC) systems indeed began to reduce data entry errors and improve monitoring capabilities in the 1990s, marking a significant leap forward from manual data entry. This advancement set the stage for today’s data accuracy standards in clinical trials. The concept of EDC systems began with the introduction of remote data entry (RDE) as early as the 1980s, helped along with the creation of computers, floppy disks, and easier connection via technology. Before this time, data collection in clinical trials were primarily paper-based and required manual entry, involving time-consuming duplicated efforts for staff; naturally, these traditional methods were associated with a greater risk of data errors and inconsistencies.  

Since their introduction, EDC systems have expanded to cloud-based platforms to provide greater scalability, flexibility, and real-time accessibility, enabling faster, more efficient clinical trials. Newer technology has also emerged, allowing for the integration of EDC with digital clinical tools such as clinical trial management systems (CTMS), electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), and electronic consent (eConsent). Today, EDC systems are almost universally used across the pharmaceutical industry, and they have become indispensable tools for maintaining appropriate quality in clinical trials.  

9. Fact or Fiction: Stringent Quality Measures are Too Expensive and Slow Down Trial Progress

Fiction: Lack of funding is admittedly a common limiting factor when it comes to quality improvement initiatives, but despite requiring initial investment, stringent quality measures often lead to cost savings in the long run. Even small changes can make a big impact on the efficiency of a clinical trial by leading to more targeted resource allocation and utilization, which can further reduce costs while improving patient safety and care. The relationship between limited investment in quality assurance measures and patient outcomes can be seen in low- and lower-middle-income countries, which still have a much higher rate of maternal and pediatric mortality compared to upper-middle-income countries.  

Understandably, there may be a systemic cost barrier in certain regions to obtaining tools and technology that can improve efficiency in clinical trials, which highlights the need for more funding in quality management initiatives worldwide. After the upfront costs, proactive quality assurance strategies can prevent costly errors, reduce the need for extensive repetition of work, and avoid regulatory compliance issues that could delay trial completion or product approval.  

10. Fact or Fiction: Once a Trial is Underway, It is Too Late to Implement New Quality Measures

Fiction: It is another misconception  that sponsors and CROs must choose and finalize all quality assurance measures by the time of clinical trial initiation.. While this may be the ideal, the reality is that no study will ever be perfect from the outset, making continuous improvement an inevitability that must be anticipated and embraced. There is always time and room to implement new quality strategies or refine existing ones to significantly improve trial outcomes. In support of this, the U.S. FDA encourages sponsors to adopt a quality-by-design approach, which involves ongoing assessment and improvement of quality throughout the trial lifecycle.  

This concept of pre-planning adjustments to a study is also the basis of adaptive clinical trials, which allow for the preplanned modification of an ongoing clinical trial based on the accumulating evidence, often patient data collected up to the point of interim analysis [17]. Adaptive designs better represent the dynamic nature of this industry and allow greater flexibility for sponsors and CROs to make quality adjustments on a continuous basis throughout the study.  

Conclusion 

In conclusion, quality in clinical trials is about more than just compliance. Instead, it is about ensuring patient safety, data integrity, and scientific rigor. In this blog, we debunked common myths and highlighted key truths about quality assurance to demonstrate that it is a dynamic, collaborative effort that extends beyond regulatory compliance requirements. By staying informed about best practices and remaining flexible in their approach, sponsors and CROs can conduct trials that are not just compliant but integrate quality patient-centered practices that safeguard patient safety. 

As we approach World Quality Week 2024 this November 11-15, join TFS CRO and the CQI/IRCA in celebrating the indispensable efforts of quality management professionals across the healthcare industry and beyond! 

About TFS HealthScience Drug Safety & Pharmacovigilance CRO 

TFS HealthScience CRO is a leader in Drug Safety & Pharmacovigilance, consistently supporting pharmaceutical sponsors with experts adept at setting up, managing, and optimizing product safety needs throughout the entire clinical development pipeline. Our commitment to flexibility and tailored services set us apart in the industry and our teams understand that safety monitoring is fundamental to protecting trial participants and ensuring strict regulatory compliance. By complying with the latest quality assurance standards in healthcare, TFS can ensure that our customers’ clinical trials are conducted with the highest safety and efficiency standards, adapting in real-time to changes and maintaining robust data integrity and participant protection throughout the trial’s lifecycle.  

Visit our website to learn more about the comprehensive quality assurance and drug safety solutions TFS CRO can offer for your next clinical trial, or connect with a TFS representative today! 

Get ready to celebrate quality excellence in support of World Quality Week 2024, held each year in November! Quality assurance is generally defined as a process that helps the involved parties ensure its products meet local and industry quality standards. Throughout these last few decades alone, this process has evolved significantly from its rudimentary standards of the early days to sophisticated, patient-centered practices used today. In the realm of clinical trials and healthcare, stakeholders such as sponsors, contract research organizations (CROs), researchers, and physicians must innovate and adapt to maintain the utmost quality in the drug development process.  

From November 11 to 15, 2024, TFS HealthScience CRO is joining the efforts of the Chartered Quality Institute (CQI) and its International Register of Certified Auditors (IRCA) in this year’s global campaign to raise awareness of the quality management profession. In celebration of this year’s upcoming World Quality Week, this blog will explore how quality assurance has transformed in recent years to prioritize patient safety, regulatory compliance, and continuous improvement, reshaping healthcare and clinical trials. Continue reading to discover the key milestones that define the impact of quality assurance on healthcare excellence and patient outcomes in clinical trials! 

The Early Days: Basic Standards and Reactive Measures for Patient Safety 

The early days of healthcare quality assurance primarily focused on basic standards that met the minimum required regulatory compliance using fragmented reactive measures, rather than proactively striving for excellence in patient safety. These measures involved healthcare providers and institutions relying heavily on insights provided by retrospective reviews and incident reports to determine which areas needed improvement.  

The first known instance of quality improvement documentation took place in 1854, when Florence Nightingale was sent to care for soldiers fighting the war between Great Britain and Crimea. Within six months of Nightingale’s team of nurses implementing and documenting various quality improvements, the mortality rate dropped from 42.7% to 2.2%. Florence Nightingale is thought to have been guided by evidence linking handwashing and cleanliness to disease reduction in Vienna’s maternity wards during the 1840s. Later in 1861, when the American Civil War officially began, the Sanitary Commission was founded with the purpose of promoting clean and healthy conditions in the Union Army camps and hospitals. 

Although these reactive quality assurance measures were successful in improving patient safety and care, they were likely also plagued by a lack of timeliness when addressing identified quality issues. During this time, there were no standardized policies or quality metrics in place for any implemented measures, resulting in inconsistencies in patient care quality. As a result, healthcare providers could not detect and develop solutions to systemic issues as quickly. Lastly, quality assurance during this period rarely considered the voice of patients and their families, with decisions only being made by the experiences of clinicians and administrators.  

The GCP Era: A Turning Point in Quality Assurance for Clinical Trials 

The adoption of Good Clinical Practice (GCP) guidelines marked a significant turning point in the evolution of healthcare quality assurance. These internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects set a new benchmark for quality in clinical research. The GCP guidelines are based on lessons learned from several significant historical events, dating back to 460 BC with the creation of the Hippocratic Oath, a foundational document in medical ethics.  Key events include the following:  

1906: Formulation of United States Food and Drug Act

The United States (U.S.) Food and Drug Act became the first federal law aimed at ensuring the safety and purity of food and drugs sold across the U.S. This later led to establishing the U.S. Food and Drug Administration (FDA), a national regulatory authority overseeing the safety and efficacy of drugs. 

1947: The Nuremberg Code

The Nuremberg Code was developed in response to the unethical experiments conducted on prisoners of war during World War II. It laid the foundation for ethical principles in all research involving humans, emphasizing voluntary consent and the need for scientific justification.  

1948: Declaration of Human Rights

This declaration was developed following the devastating atrocities of World War II to establish a common standard for the fundamental rights and dignity of all individuals, namely the importance of ethical considerations and the protection of human subjects.  

1964: Declaration of Helsinki

The World Medical Association’s Declaration of Helsinki introduced guidelines for medical researchers, emphasizing the importance of ethical considerations, informed consent, and scientific rigor in clinical trials. 

Visit this page for more information on the historical events that led to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), establishing its GCP guidelines across regions such as the U.S., European Union, and Japan. 

The implementation of GCP guidelines ensured that the rights, safety, and well-being of trial subjects were protected, consistent with the principles of the Declaration of Helsinki, while ensuring that clinical trial data were credible and accurate [5]. The most-recent and widely used update was in 2016, where ICH released “E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1),” introducing updated requirements for risk-based monitoring, electronic records, and informed consent, aligning GCP standards with contemporary research needs. This shift towards standardized practices in clinical trials had a ripple effect on broader healthcare quality assurance practices, emphasizing the importance of systematic documentation, strict protocol adherence, and rigorous ethical considerations in healthcare delivery.  

Ensuring Patient Safety Proactively: The TQM and CQI Methodologies 

As quality assurance continued to evolve throughout the 20th century, there was a growing recognition of the need for more proactive and comprehensive approaches, which then led to the development of Total Quality Management (TQM) and Continuous Quality Improvement (CQI) methodologies in the healthcare industry. The TQM and CQI are broadly defined as follows:  

• TQM is “the management philosophy and system that promotes positive organizational change, as well as an effective cultural environment, for continuous improvement of all aspects of the organization.”
• CQI is “a systematic approach to the measurement, evaluation and improvement of the quality of all products and services, through the use of disciplined inquiry and teamwork.”

TQM and CQI emphasized the importance of involving all stakeholders in the quality improvement process, from frontline staff to senior management. They introduced concepts such as process mapping, root cause analysis, and PDCA (Plan-Do-Check-Act) cycles, which became fundamental tools in healthcare quality assurance. This era also set the stage for increasing awareness about patient-centered care as a core principle of quality assurance, with clinicians and healthcare institutions beginning to recognize that patient or staff satisfaction and engagement were crucial indicators of quality. This resulted in more widespread incorporation of patient feedback and experiences into quality improvement initiatives in the last few decades. 

CROs Drive the Tech Revolution: Data-Driven Quality Assurance  

As we reach modern day quality assurance in this article’s historical timeline of how quality management has evolved over the years, the impact of advancements in data management technology and data analytics tools cannot be understated. Electronic health (eHealth) and mobile health (mHealth) facilities, along with electronic health records (EHRs) and artificial learning (AI) models, have enabled more powerful big data analytics. The emergence of big data analytic tools has opened the door to analyzing databases on a much larger scale. The rise of big data has since promoted research into its applications in healthcare, imaging, smart technology, tracking and transportation systems, and more.  

As quality assurance becomes digitized using increasingly sophisticated technologies, healthcare providers have been able to adopt a more comprehensive oversight process known as risk-based monitoring. Risk-based monitoring allows for the identification of potential issues before they escalate, enabling more targeted and efficient monitoring of quality in patient care and healthcare delivery. A 2023 study found that 88% of clinical trials had adopted at least one of these components of risk-based monitoring as of 2021, an increase from 77% in 2020. Unlike the reactive measures seen in the early days of quality assurance, modern day strategies are taking a more preventative, proactive approach to maximize excellence and improvement. These technological innovations, along with the rise of telemedicine, are providing clinicians with a wealth of information to support evidence-based decision-making and data-driven quality assurance in healthcare.  

Interested in learning about how TFS CRO is approaching drug safety monitoring in clinical trials? Read our insights in this article! 

A Holistic Perspective: A Systems-Based Approach with Patient-Centered Practices 

Most recently, the focus of quality assurance in healthcare has shifted towards a more holistic, systems-based approach. This perspective recognizes that healthcare quality is influenced by several factors, including organizational culture, leadership, communication, and systemic processes. Adopting a systems approach has led to the development of comprehensive quality management systems (QMS) that integrate various individual quality assurance tools and methodologies. Healthcare and clinical research institutions are also placing more emphasis on creating a company culture of safety, constructive feedback, and continuous improvement, especially since the COVID-19 pandemic. It’s also important to note that more and modern quality assurance measures in healthcare are incorporating metrics to assess and improve cultural competence, language access, and health literacy to ensure that quality healthcare is accessible to diverse patient populations. 

Looking Ahead: The Future of Quality Assurance in Healthcare 

In conclusion, the landscape of quality assurance in healthcare will continue in its upward trajectory towards even greater innovations, as the technological capabilities of data analytics become more advanced. Above all the potential opportunities for the future, the integration of AI/ML techniques is the most exciting. These algorithms can be expected to strengthen the predictive capabilities in quality assurance, allowing for even more proactive and personalized approaches to patient care. Other possible trends in quality assurance strategies may include the emergence of more harmonized international quality standards and practices, as well as a greater emphasis on sustainability, both in terms of environmental impact and long-term health outcomes.  

As we approach World Quality Week 2024 this November 11-15, join TFS CRO and the CQI/IRCA in celebrating the indispensable efforts of quality management professionals across the healthcare industry and beyond! 

About TFS HealthScience Drug Safety & Pharmacovigilance CRO 

TFS HealthScience CRO is a leader in Drug Safety & Pharmacovigilance, consistently supporting pharmaceutical sponsors with experts adept at setting up, managing, and optimizing product safety needs throughout the entire clinical development pipeline. Our commitment to flexibility and tailored services set us apart in the industry and our teams understand that safety monitoring is fundamental to protecting trial participants and ensuring strict regulatory compliance. By complying with the latest quality assurance standards in healthcare, TFS can ensure that our customers’ clinical trials are conducted with the highest safety and efficiency standards, adapting in real-time to changes and maintaining robust data integrity and participant protection throughout the trial’s lifecycle.  

Visit our website to learn more about the comprehensive quality assurance and drug safety solutions TFS CRO can offer for your next clinical trial, or connect with a TFS representative today! 

Click here to learn how effective safety monitoring with the right CRO partner can lead to cost savings in clinical trials. 

Dermatology clinical trials are not much more different than those of other therapeutic areas, but they have certain unique characteristics. Topical drug development makes up a large portion of clinical research for treating skin diseases, but because these are often combined with other topical vehicles (whether placebo or another inert emollient), the placebo rates might be higher in dermatology than in other specialties. Data management strategies ensure consistent and reliable quality of clinical trial data, otherwise sponsors and contract research organizations (CROs) would run into notable data quality risks. Without choosing the right data management plan with appropriate advanced statistical methods, a clinical study cannot accurately demonstrate the safety and efficacy of an experimental dermatological drug.

Several solutions have emerged at the forefront of data management innovation within dermatology clinical trials. In this article, we will delve into various digital tools—from AI-powered data cleaning to wearable devices—that are streamlining patient data collection, improving trial efficiency, and enhancing patient outcomes in this therapeutic area. Continue reading to discover how these advancements are furthering clinical research in dermatology and driving more accurate, efficient, and patient-centered clinical trials!

1. Artificial Intelligence for Efficient Data Cleaning Processes in Clinical Trials

Dermatology clinical trials, like all other studies, generate massive volumes of data throughout their lifecycle, which then must undergo data cleaning before they can support clinical decision-making. Data cleaning involves identifying and correcting or removing errors, inconsistencies, and inaccuracies in datasets, making this a fundamental process for interpreting study results accurately. If done manually, this process can be tedious, time-consuming, and prone to human error for data scientists, but the advent of artificial intelligence (AI) offers a more efficient alternative solution for these clinical trials.

Probabilistic programming is a subspeciality of AI technology that uses statistical methods to infer uncertain statements. In 2021, MIT researchers introduced a digital system called “PClean,” which uses several probabilistic programming languages and a knowledge-based approach to automate the data cleaning process. This article explains that users can provide PClean with background knowledge about the dataset, such as correct study data in the case of clinical trials, and how it can be corrupted with errors. PClean’s repairs are based on Bayesian reasoning, an approach that weighs alternative explanations of ambiguous data by applying probabilities based on prior knowledge to the data at hand.

A previous analysis estimated that inaccurate data could be costing the US as much as 3.1 trillion dollars a year, highlighting a significant opportunity for AI-powered data cleaning tools to streamline the process. Syneos Health, another CRO, reported that using AI and machine learning (ML) technologies for data capture cleaning can reduce the time burden of manual data cleaning by more than 3000 hours. Systems like PClean, Quadient Data Cleaner, and many others can be applied in dermatology clinical trials to run data cleaning and validation tasks in real-time for even the most complex and large-scale datasets.

Read our recent article here to discover the role of AI in clinical research.

2. Patient Wearable Devices Enable Real-Time Data Monitoring

There is currently no standardized methodology for tracking disease progression and treatment response in dermatology clinical trials. More importantly, many skin conditions deeply affect a patient’s quality of life but measuring this impact can only be done using patient-reported psychometric outcomes. With mobile health (mHealth) and wearable technology advancing rapidly in recent years, more clinical trials are now able to integrate these tools into dermatological research to collect real-time continuous data on a patient’s skin health.

Smart devices worn on the body can now monitor a wide range of parameters relevant to dermatology, including UV exposure, skin hydration levels, and even early signs of inflammatory responses. Sponsors and CROs can implement these devices during a study to remotely collect longitudinal data (including day-to-day fluctuations) on participants’ skin conditions, providing patients with greater convenience. The use of electronic devices also provides new opportunities to introduce standardization procedures into data collection for dermatology clinical trials, making robust inter-study analyses possible.

Furthermore, these devices enable a dermatology study to collect a wider variety of data from which ML algorithms can be applied to gain insights, such as identifying groups who are high-risk for flare-ups of their psoriasis or eczema, detecting optimal patterns to improve treatment adherence, or leveraging these data to make predictions of disease outcomes. These devices, with or without the use of AI/ML tools, are applicable broadly to several skin conditions and have demonstrated their potential for promoting personalized, data-driven dermatology clinical trials.

3. Stringent Data Security Regulations Must Safeguard Patient Data

Dermatology clinical trials are unique in that they often rely heavily on visual data in the form of photographs of participants to represent disease progression and treatment responses. Without the appropriate safeguards in place, these clinical images have the potential to infringe on a patient’s right to data security and privacy, as well as cross the ethical boundaries of patient-physician interactions. In the United States (U.S.), the most notable regulation governing patients’ rights to privacy is the U.S. Health Insurance Portability and Accountability Act (HIPAA).

The HIPAA provides valuable guidance for sponsors, CROs, and data-related stakeholders to remain compliant with best practices for stringent data security in dermatology clinical trials. For example, to protect a patient’s identity in clinical photographs, the images should be cropped to remove nonessential identifying details, such as clothing, tattoos, birthmarks, or jewelry. This must be done so that the cropping does not remove any diagnostic disease features or details of response to treatment. This 2023 article by Shinkai et al. also notes that masking or blurring the eye region in photographs does not assure anonymity and is not acceptable.

In terms of promising digital tools, blockchain technology could provide a reliable framework for securely storing and sharing medical records, clinical trial data, and research findings. Blockchain is a decentralized, unalterable digital ledger of all data transactions, ensuring a greater level of transparency and traceability in dermatological research. Importantly, blockchain’s cryptographic protocols allow for secure sharing of sensitive patient information among authorized parties while maintaining strict control over access rights. Learn more about how blockchain technology is improving clinical research quality here!

4. Pursuing Data Management Solutions that Offer Scalability Across Therapeutic Areas

Dermatology is not the only therapeutic area that can benefit from the latest innovations in data management solutions. As the clinical trials industry increasingly implements more efficient methods of data collection, analysis, and storage, the ones with the greatest potential are those that offer scalability across other medical specialties. For example, the earlier article about MIT’s PClean explained that this AI-powered data cleaning system uses generic common-sense models that can be customized to various databases and types of errors.

Image-recognition technology in ML deep learning models that can glean insights from clinical images of dermatological diseases can also be applied to fields like radiology or diagnostic imaging to enable more accurate diagnoses. Similarly, wearable devices and mHealth are already being utilized in cardiology to track patients with heart conditions in real-time, enabling faster medical intervention in the case of an emergency. As these technologies are implemented across different fields, they can create a more interconnected healthcare ecosystem that enhances the quality of care in individual specialties beyond dermatology.

The Future of Data Management in Dermatology Clinical Trials

As we have discussed in this article, there are several new opportunities for innovation in data management technology within dermatology clinical trials. However, realizing the full potential of these technologies will require overcoming several hurdles. First, one of the challenges of utilizing available databases to their fullest extent is the challenge that lies in standardizing data formats and protocols across different systems and institutions. Although AI/ML data cleaning systems may alleviate interoperability issues caused by this limitation, additional measures may be required to set standards for data collection and formatting in clinical trials.

Concerns about data security and privacy must also continue to be addressed, especially as emerging technologies enable greater data collection from patients. Providing training and education to physicians, researchers, and patients about devices like wearables, AI-based data management tools, and the latest updates to regulatory policies can better safeguard patient data in clinical trials.

Interested in learning more about the latest trends emerging this year in dermatology clinical research? Visit this article here!

Despite these challenges, the technologies and solutions discussed in this article present an exciting future in dermatology where the drug development process is increasingly streamlined, more personalized, and more secure. As these technologies continue to evolve, sponsors and CROs may also be able to promote new data management standards in therapeutic areas beyond dermatology clinical trials.

TFS CRO: Your Industry Partner in Data Management

At TFS HealthScience, we understand that strong data management is the foundation of a successful clinical trial. Our Data Management & Biostatistics team combine cutting-edge technology with seasoned expertise to deliver unparalleled accuracy and efficiency in clinical trials for clients worldwide. From study design to database lock, you can expect data integrity, compliance with regulatory standards, and seamless integration across all study phases. Our adaptive approach allows us to tailor our services to your unique needs, ensuring that your data not only meets but exceeds industry standards.

Ready to transform your clinical data management and biostatistics experience? Contact a TFS representative today or visit our website to learn what solutions we can offer for your next clinical trial!

Biopharmaceuticals make up a significant portion of the pharmaceutical market, and as of 2024, the biopharma market size was estimated to be over US$400 billion with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. Even more substantial is the growth being observed in the biotechnology sector; in 2020, the market size for biotech was nearly US$500 billion and had an estimated CAGR of 9.4% between 2021 and 2027. These industries are developing rapidly largely due to advancements in technological capabilities, evolving regulatory frameworks, and a shift towards patient-centered care in clinical trials.

Although such fast-paced change undoubtedly comes with some challenges, the dynamic landscapes of the biopharma and biotech industries also present exciting opportunities for clinical trial sponsors, pharmaceutical firms, contract research organizations (CROs), and biotech startups. In this article, we will explore five key predictions for the biopharma and biotech sectors in 2025, examining how emerging trends and innovations are expected to shape the future of medicine. These predictions provide a glimpse into a future with healthcare that is increasingly personalized, efficient, and accessible for all.

Read on to discover our top five predictions for the 2025 biopharma and biotech industries!

1. Accelerated Clinical Trial Designs Reshape Drug Development

As our understanding of human diseases grows, clinical trials in therapeutic areas such as oncology, neuroscience, rare disease, and several others have become increasingly complex. To promote more efficient timelines and avoid exposing too many patients to ineffective therapies, we can expect to see traditional clinical trials shift toward more innovative study designs in 2025.

According to the United States (U.S.) Food and Drug Administration (FDA), adaptive clinical trials allow for planned modifications based on interim data analysis, enabling researchers to optimize study protocols in real-time. The adaptive design is increasingly being explored as a more efficient alternative to traditional trial models because they can reduce the time and cost associated with bringing new therapies to market, but also increase the likelihood of predicting the efficacy of an experimental drug early in the pipeline. For example, if at interim analysis the primary endpoint (e.g., overall survival) is lower than expected, the trial can be terminated early on. Conversely, if the data is more positive than expected, the sample size can be increased knowing patients are likely to benefit from the experimental drug.

We will likely also see a greater emphasis on using synthetic control arms (SCA), which are derived from historical real-world evidence (RWE) using advanced statistical methods. Implementing an SCA eliminates the need for enrolling placebo groups in certain clinical trials, which can improve retention rates because patients are guaranteed to receive the experimental therapy. With this approach, researchers can increase their trial’s generalizability with more diverse populations being represented in the data.

Further, more sponsors and CROs are embracing decentralized clinical trials, or trials with decentralized components, by leveraging advanced digital health technologies to enable remote patient monitoring and data collection processes. Benefits of DCTs include greater cost-effectiveness, improved trial accessibility to underserved populations, greater convenience for participants, and more efficient resource allocation.

2. Regulatory Landscape Evolves to Keep Pace with Innovation

With the expected shifts toward more innovative trial designs, rather than traditional study models, the regulatory landscape in the biopharma and biotech industries can be expected to undergo similar change in 2025. Agencies like the U.S. FDA and the European Medicines Agency (EMA) are striving to keep pace with rapid technological advances driving increasing complexity within clinical trials, as well as evolving healthcare needs worldwide. Most recently, in September 2024, the FDA released their final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested Parties” (CTDE guidance). This builds on prior drafts to highlight the agency’s continued support of well-designed DCTs, but also provides valuable insights into unique challenges they may present. Read more about the latest FDA guidance document on DCTs here.

Regulatory agencies are also changing to eliminate inefficiencies in the drug review process. Notably, January 31, 2025 marks the end of the three-year transition period granted to sponsors with ongoing clinical trials since the Clinical Trial Regulation (CTR) No 536/2014 became applicable in the European Union (EU) in January 2022. The purpose of passing the CTR was to enable better efficiency in the regulatory process for new trials because sponsors can apply for clinical trial authorization in up to 30 European countries with only a single application. As we quickly approach this deadline, sponsors and CROs operating in the EU will need to transition fully to the use of the Clinical Trials Information System (CTIS) regulatory platform. To learn more, visit our article on the Evolving Landscape of EU Clinical Trials Post-Regulation.

3. Precision Medicine Takes Center Stage in Medical Innovation

Precision medicine is already taking center stage in several therapeutic areas, particularly oncology and rare diseases, but we can expect it to grow further into a cornerstone of medicine in 2025. Also known as personalized medicine, this approach tailors disease prevention, diagnosis, and treatment strategies to individual patients based on their unique genetic, lifestyle, and environmental factors. As we approach the new year, we may see significant changes in the clinical applications of precision medicine in the biopharma and biotech industries. For example, as genetic testing becomes routine practice in healthcare, the genetic causes of common disorders can be identified, resulting in a surge of novel targeted therapies entering clinical trials.

Earlier this year in April, the National Human Genome Research Institute (NHGRI) convened to discuss strategies for large-scale utilization of genomic sequence data in delivery of genomic healthcare. As we enter 2025, electronic health records (EHR) will make strides in becoming genome-aware and make pharmacogenomics more accessible. We may also see such data be moved more easily between the EHR and other secure databases such as patient-facing health apps or clinical trial recruitment platforms. In fact, this 2024 published Nature article introduced an open-source Python framework using deep learning models for end-to-end analysis of EHR data.

Such database frameworks assisted by machine learning (ML) algorithms, sponsors, CROs, and investigators can perform end-to-end analysis of genomic data in EHRs to create well-defined patient subgroups in clinical trials. Precision medicine strategies can also match patients to effective therapies more accurately using genetic data.

4. Patient-Centric Approaches and Sustainability Drive Industry Transformation

We are already seeing a significant shift towards more patient-centric approaches and sustainable practices in clinical trials, but they will likely become more widespread in 2025. Sponsors and CROs will place an increasingly greater emphasis on patient perspectives and experiences throughout the drug development processes. We can expect to see more clinical trials adopting digital health technologies, such as wearables and mobile health (mHealth), to enable remote patient monitoring and continuous data collection. As these devices are widely implemented, study protocols can include fewer visits requiring patients to come on-site. Digital health technologies, especially when combined with DCTs, offer participants more convenient trial experiences, while expanding the study’s reach to geographically isolated patient populations.

Learn more about digitally-enabled, patient-centric clinical trial design in this publication here.

Interested in how patient-centric approaches can enhance pediatric rare disease studies? Watch our webinar here!

Sustainability will also become a greater focus for the biopharma and biotech industries, with more companies implementing eco-friendly principles in drug manufacturing, reducing waste, and minimizing their overall carbon footprint. Recently, TFS released an article discussing key strategies being adopted by CROs and sponsors to make clinical trials more sustainable. These approaches involved running more virtual or DCTs, streamlining data management with digital data capture over paper-based traditional methods, and reducing clinical trial waste by optimizing drug supply chain management and transportation of materials to clinical research sites.

Read the full article here.

Discover how TFS HealthScience CRO is making significant strides in environmental stewardship, social responsibility, and sustainable business practices in our 2023 Sustainability Report.

5. Artificial Intelligence Revolutionizes Drug Discovery and Development

Artificial intelligence (AI) and ML frameworks are already presenting novel opportunities for change in medicine and clinical research, and it will only continue to expand its impact on these fields in 2025. From optimizing drug screening methods to streamlining clinical trials, AI/ML technologies offer greater speed and accuracy in their ability to process and analyze large volumes of data. Based on the growing success of these algorithms in the biopharma and biotech industries, the market size of AI in healthcare is forecasted to skyrocket from a value of US$13.6 billion in 2022 to US$164.1 billion by 2029.

As described in this 2024 review, AI/ML models have shown promise across each stage of the drug development process. During preclinical drug screening and optimization, AI was used to analyze molecular images of the effects of drugs on a cell, using deep generative modeling to design virtual novel candidate molecules. In drug target discovery, ML algorithms mined existing genomic, chemical, and clinical databases to find previously unknown connections for novel molecular targeting. Finally, AI/ML was applied to conduct clinical outcome analysis using pattern-recognition approaches that identified correlations between immune responses and patient survival. Although the review found these applications were focused primarily on anticancer and neurological therapies, in 2025, we can expect to see more therapeutic areas benefit from AI/ML analytics.

Conclusion

In 2025, the biopharma and biotech industries will continue to undergo a significant shift defined by unprecedented scientific breakthroughs and exciting technological innovation. The five predictions outlined in this article, from evolving clinical trial designs and regulatory frameworks to a rise in precision medicine and AI/ML technologies have already begun to shape pharmaceutical research. As we begin to close out 2024, key stakeholders such as study sponsors, CROs, principal investigators, and patients can look forward to a greater focus on patient needs, ethical and sustainable practices, and improved efficiency in the clinical trials industry.

TFS CRO: Your Industry Partner in Data Management

At TFS HealthScience, we understand that strong data management is the foundation of a successful clinical trial. Our Data Management & Biostatistics team combine cutting-edge technology with seasoned expertise to deliver unparalleled accuracy and efficiency in clinical trials for clients worldwide. From study design to database lock, you can expect data integrity, compliance with regulatory standards, and seamless integration across all study phases. Our adaptive approach allows us to tailor our services to your unique needs, ensuring that your data not only meets but exceeds industry standards.

Ready to transform your clinical data management and biostatistics experience? Contact a TFS representative today or visit our website to learn what solutions we can offer for your next clinical trial!

Clinical trials are not an easy undertaking, considering the exorbitantly high costs associated with running them, as well as the many pitfalls that can hinder their success. A 2022 publication by Sun et al. estimated that 90% of drug candidates that reach clinical trials will fail during Phase 1-3 clinical trials and drug approval by the United States (U.S.) Food and Drug Administration (FDA). Similarly, Thomas et al. (2021) found the chances of a new drug reaching the market successfully from conception was only 7.9%, despite the large amounts of time and money commonly invested in clinical trials. These numbers explain why drug development is not a process that can be rushed and underscores the importance of sponsors selecting the right contract research organization (CRO) to ensure their trial’s success. However, success depends on far more than just CRO selection.

At its core, the sponsor-CRO dynamic is a partnership and thrives best when there is open, collaborative communication on a continuous basis. It is crucial for sponsors to feel comfortable asking their CRO the right questions because they can help you stay informed, address challenges proactively, and make necessary adjustments to keep your trial on track. In this article, we will highlight ten essential questions that can help sponsors gain valuable insights from their CRO partner, optimize study outcomes, and, ultimately, foster a stronger partnership in which both parties demonstrate their commitment to the clinical trial’s success.

Read on to learn how asking your CRO these ten questions can help optimize your ongoing study!

Question 1: Are we on track to meet our initial timelines, and if not, what adjustments are being made?

Reasoning: Approximately 86% of clinical trials experience delays during startup, and for every day of delay, the pharmaceutical industry stands to lose anywhere from US$600,000 to US$8 million. These stark numbers emphasize the importance of asking about the current status of your study relative to the initial timelines, because it can offer critical information that helps minimize financial consequences. Sponsors should also consider that initial timelines are typically based on best-case scenarios, and it is common for unforeseen challenges to come up.

In that case, ask whether your trial’s current status stands relative to the original timeline, as well as touch on any delays that may need to be addressed. Problems will be identified in every study, which is the nature of clinical development, but the right CRO will be transparent and able to propose adjustment strategies to overcome unexpected obstacles and help your study stay on track. By asking this question, sponsors and their CROs can work together to identify potential problems, find solutions, and keep their clinical trials moving forward effectively.

Question 2: How confident are you in hitting the target for First Patient In (FPI) based on current site readiness and patient recruitment efforts?

Reasoning: The FPI is an important milestone in clinical trials when the first patient is randomized into a study, marking its transition from preparation to active trial enrollment. Meeting an FPI target can help keep study timelines on track more successfully, but the key to success is to ensure that this initial target be realistic. Many sponsors may be swayed by promises of unrealistic timelines from CROs, but this is a common pitfall. In practice, FPI targets can shift drastically depending on the therapeutic area or indication, your trial’s protocol or eligibility criteria, the extent of available site support, whether a local or central institutional review board (IRB) was chosen, and many other factors. By evaluating the answer to this question with realistic assessments and relevant data from your CRO, sponsors can avoid future issues and are less likely to enact a contingency plan.

For example, the CRO can provide information about how many sites have been fully activated, whether there are backup sites that can be activated if needed, and what challenges may be contributing to any delays. If FPI takes place more than 30-60 days after the initial target, there may be a delay in enrollment timelines, in which case CROs can enact their contingency plan to ramp up recruitment efforts. The goal for sponsors when asking this question is to maintain an open dialogue with their CRO and identify any areas where sites may need additional support to reach activation and begin enrolling participants.

Question 3: How is our site performance and patient enrollment progressing compared to other similar studies you’ve managed?

Reasoning: Question 3 serves several purposes, including measuring your trial’s progress against industry standards, determining the CRO’s prior experience with similar studies, and whether they can suggest some best practices that have worked before. This is particularly valuable when working with a CRO like TFS that has a long-standing history running clinical trials because they can provide meaningful comparisons. In response to this question, sponsors should inquire about whether their study’s site activation or patient enrollment rates are comparable to those of other studies, and if so, what the underlying reasons might be.

What factors may be contributing to your clinical trial outperforming other similar ones in these aspects? Or if it is lagging, what unique challenges is your trial facing that others did not? Asking these insightful questions can invite the CRO to share strategies from their previous successful studies that could be applied to address any persisting challenges. Leveraging important lessons from case studies is crucial for helping streamline future studies because they can help sponsors avoid common pitfalls.

Question 4: What changes or unexpected challenges have surfaced, and how are they being handled to keep the study on track?

Reasoning: Changes and unexpected circumstances are inevitable with any clinical trial, which means this question is crucial for understanding your CRO’s approach in proactively identifying potential problems. Beyond detecting any issues, this question serves to determine what detailed solutions have been planned. This includes setting up robust action plans to address concerns like regulatory hurdles, supply chain issues, delayed patient recruitment, etc., that consider your trial’s current status relative to the original plan.

To ensure a strong partnership, concerns such as these, including any supporting data, should be communicated with full transparency and in a timely manner to promote team-based problem-solving. Following this, when solutions are proposed by the CRO, take the time to discuss how well they suit your study’s overall goals and timelines. Some approaches may only provide short-term relief, whereas others rely on thoughtful strategies that can be sustained long-term to keep your study on track.

Question 5: Can you foresee any changes in scope that would require additional resources or costs not originally discussed?

Reasoning: A 2024 economic evaluation study analyzed the development costs of clinical trials conducted between 2000 and 2018, finding that the mean cost of developing a new drug was approximately U.S.$172.7 million. This value increased nearly five-fold to U.S.$515.8 million when cost of failures was included, suggesting the importance of discussing budget expectations between sponsors and CROs. However, such a topic should be approached in  a way that both parties feel comfortable sharing potential changes with each other before coming to an agreement about how best to proceed. For example, based on current study metrics, the CRO may notice more site activation, longer enrollment periods, or increased monitoring visits are needed, all of which require additional resources and costs.

While overextended clinical trials budgets are not ideal, sometimes investing in a seasoned CRO, who can predict future needs based on early indicators, can help clinch your study’s success. Responses to this question can help explain the rationale behind new changes in scope and how to keep increased costs and resource use within a reasonable range. Scope changes happen and the goal is not necessarily to avoid them; rather, sponsors should use this question to ensure the changes are justified and communicated early enough to address easily.

Question 6: What is your current assessment of patient recruitment and retention strategies, and do we need to make any adjustments to meet targets?

Reasoning: Patient recruitment and retention are the two most significant bottlenecks every clinical trial sponsor must overcome with their study, with recruitment often taking up nearly 30% of development timelines and requiring over US$1 billion of spending. The goal of asking this question is to get a comprehensive look into the CRO’s current strategies, their adaptability in different scenarios, and a summary of recruitment and retention efforts from previous successful trials. Important quantitative data to consider are the number of patients screened, enrolled, and retained, as well as how these numbers compare to the initial targets.

Beyond that, use this question to determine whether digital technology is being leveraged to boost enrollment. For example, many CROs will take advantage of social media campaigns, patient engagement apps, or third-party digital recruitment specialists. Read this publication here about how digital recruitment can improve trial diversity and inclusion.

The sponsor can also inquire about what recruitment challenges are being observed and whether previously successful strategies can be applied to your study to overcome them. Experienced CROs regularly collect data on recruitment and retention rates, providing a real-time look into which regions might need more targeted efforts, whether back-up sites should be considered and where, and what additional patient support can be provided.

Question 7: How are our relationships with trial sites progressing, and are they fully engaged to meet study goals?

Reasoning: This question is designed to assess the quality of relationships between your CRO and the participating sites, as well as the sites’ level of commitment to your study because the success of clinical trials depends on the success of their investigative sites. Sponsors should consider both quantitative and qualitative metrics from their CRO. Quantitative data might include site activation rates, patient enrollment numbers per site, data quality, and protocol adherence. Equally important are qualitative accounts from the CRO about their ground-level experiences with a site, what kind of support mechanisms are in place, and whether challenges expressed by site staff are being proactively managed.

Clinical research sites are the backbone of a clinical trial and both the sponsor and its CRO should strive to understand what factors contribute to standout sites and underperforming sites alike. Recognition announcements, motivational initiatives like authorships on publications, or additional support for underperforming sites can also go a long way in improving engagement. Overall, this question helps ensure your CRO is creating long-term, positive relationships with investigative sites in a way that aligns with your organization’s values.

Question 8: How are recent industry developments, such as regulatory changes or drug approvals, influencing the direction of our study?

Reasoning: The regulatory landscape of clinical trials is constantly evolving staying ahead of changes is not just a best practice—it is a necessity. It is the responsibility of every stakeholder involved with a clinical study to remain vigilant about these changes, ensuring diligent compliance. With this question, sponsors can ask CROs about their familiarity with the broader industry landscape and how they may plan to adapt to changes accordingly. If the FDA, Health Canada, or the European Medicines Agency (EMA) recently released new guidelines relevant to your clinical trial, the right CRO will have already known and considered how your trial may be impacted. Thoughtful analysis of any changes and their impact would ideally involve a discussion of risks and opportunities in the industry, and what proactive measures are being explored.

For example, is there a new designation pathway that could expedite your drug’s approval? Do the changes in regulations necessitate a protocol amendment that is already under development by the CRO? Has a competing drug recently received an approval that may call for certain changes to your study’s design or patient population? This question is important for sponsors to ask because it confirms how far forward your CRO is thinking and whether they anticipate future trends that could affect your study.

Question 9: Are there any operational or logistical bottlenecks we haven’t yet addressed that could slow down study progress?

Reasoning: Aside from the primary bottlenecks that most clinical trials experience, covered earlier with Question 6, it is equally important to ask your CRO more broadly about other potential issues that may not be as apparent. Some specific examples they may provide could include delays in drug supply, recurring issues with data management systems, certain trial activities being associated with more protocol deviations than expected, or obstacles posed by regulatory tasks. As with other bottlenecks, after identifying and communicating these, this question can help the sponsor understand the CRO’s strategies to avoid slowing study timelines or extending the budget.

In many cases, contingency plans may involve having backup vendors, system processes, or training materials prepared so any sudden operational or logistical obstacles can be overcome more easily. Of course, we cannot predict every challenge that arises, but using this question to determine whether your CRO is strategically thinking about high-priority bottlenecks can help save your clinical trial a significant amount of time and money.

Question 10: What feedback are you receiving from sites and patients, and how are we incorporating that into our ongoing strategies?

Reasoning: With this last question, sponsors can gain valuable insights about the practical feedback CROs have received from participating sites and patients. Often, study protocols are designed only to maximize the chances of successful scientific outcomes, but may not directly factor in the patient’s experience. Examples of constructive comments from sites could involve insufficient support or issues with the protocol, or conversely, positive patient experiences with the drug or strong support from their assigned clinical research associate (CRA).

However, the most important component of this question is how this feedback is being incorporated to optimize site and patient satisfaction. Concrete ways a CRO can address these comments include allowing reasonable accommodations with study procedures to improve patient centricity, expediting communications for the site in the event they need additional support or equipment, as well as participating in collaborative discussions with site staff about potential solutions when a problem is identified.

Conclusion

In conclusion, asking these 10 key questions to your CRO can significantly improve the chances of your clinical trial being successful. Ultimately, the purpose of these questions is to encourage open communication and transparent teamwork between sponsors and flexible, accommodating CROs . Inquisitively requesting vital information about a study from startup to close-out can help address potential challenges earlier and ensure both you and your CRO are on the same page. This can include aligning expectations with recruitment strategies, site relationships, budget expectations, changes to study timelines, regulatory compliance and more. Regularly engaging by using these questions only strengthens the partnership with your CRO because it promotes a shared commitment to your clinical trial’s goals and success.

About TFS HealthScience CRO

Is your clinical trial facing unexpected challenges? With deep expertise across multiple therapeutic areas and an adaptive, solution-driven approach, we’re uniquely positioned to help you ask—and answer—the 10 essential questions to get your trial moving forward with confidence. From our full-service Clinical Development Services to tailored Strategic Resourcing Solutions (SRS) and Functional Services (FSP), TFS provides the flexibility, insights, and practical experience to meet your study’s unique demands.

Choose TFS as your trusted CRO partner and experience how our commitment to proactive collaboration and scientific precision can make all the difference in achieving your clinical goals.

Explore our solutions on our website, or connect with a TFS representative today to see how we can help drive your clinical trial toward success.

Explore our website to learn more about our solutions, or connect with a TFS representative today to see how we can help drive your clinical trial toward success.