There’s no doubt that clinical trials have increased in complexity over the last decade, accompanied with several innovations including new trial designs, novel clinical endpoints, new disease biomarkers, and a greater availability of real-world data (RWD). To navigate the unique challenges of today’s clinical trials, pharma sponsors and contract research organizations (CROs) must ensure effective operational planning and strategic study coordination from the outset.  

Clinical research coordinators (CRCs), or study coordinators, are indispensable to sponsors for achieving this, serving as a direct liaison between other stakeholders, including patients, investigators, and CRO partners. The responsibilities of a study coordinator encompasses a wide variety of tasks, from patient recruitment and retention to data management and regulatory compliance. Because of their central role in clinical trial conduct and management, the efficiency and effectiveness of a research site’s CRCs will directly influence the overall quality, timeliness, and success of a study. 

Recognizing the importance of these clinical research professionals (CRPs), TFS HealthScience CRO recently shared insights to highlight and enhance the important role of study coordinators in clinical research. This article highlights key learnings, including Sponsor feedback from our TFS July Poll series, exploring critical contributions, challenges, and priorities of study coordinators in clinical research. Read on to learn more! 

 

The Critical Role of Study Coordinators in Clinical Trials 

As clinical trials become increasingly complex and regulatory requirements more stringent, the need for effective clinical research coordination has never been more important. To meet these growing demands, CRCs are crucial for ensuring smooth operations and maximizing efficiency, as explained in this comprehensive guide to study coordination services. According to the Association of Clinical Research Professionals (ACRP), “a CRC, study site research nurse, or study site coordinator, works at a clinical research site under the immediate direction of a principal investigator (PI), whose research activities are conducted under Good Clinical Practice (GCP) regulations”. These professionals typically possess a unique blend of skills, including clinical knowledge, organizational ability, strong communication, time management skills, and exceptional attention to detail.  

With their skills, CRCs support successful clinical trials through a variety of tasks, spanning administrative duties, monitoring, data management, researcher-related duties, and other clinical responsibilities. These key competencies and responsibilities enable study coordinators to maintain protocol and data integrity, facilitate clear communication with sponsors and patients, and manage day-to-day trial operations. Therefore, from start to finish, study coordinators play an essential role in clinical research, driving efficient, compliant, and high-quality clinical trials.

Continue reading to discover five key insights from TFS CRO on the valuable contributions of study coordinators in clinical research! Interested in discovering 10 more reasons to hire a study coordinator? Click here. 

 

1. CRCs are Indispensable for Streamlining Trial Operations and Improving Efficiency

The TFS CRO Strategic Study Coordination campaign revealed that skilled study coordinators significantly streamline clinical trial operations, leading to improved efficiency and cost-effectiveness. Specifically, these professionals possess strong project management skills, which are helpful for optimizing schedules, managing resources effectively, and identifying potential obstacles at a clinical research site before they become issues. From site initiation to study close-out, study coordinators are often responsible for maintaining and organizing essential documents, managing data entry and query resolution, and coordinating between various departments and external vendors. Although balancing several key roles within a clinical trial is no doubt challenging, expert CRCs are well-trained in exercising their detail-oriented organizational and time management skills to ensure the operational day-to-day aspects of a trial run smoothly. For these reasons, sponsors and CROs rely extensively on the work of an experienced study coordinator to promote faster study completion times and fewer errors, resulting in considerable overall cost savings.  

To learn more about how study coordinators drive success throughout the entire trial process, visit this roadmap to effective study coordination infographic from TFS CRO. 

 

2. How Study Coordinators Enhance Collaboration and Address CRO Pain Points 

In their role as a communication liaison between sponsors, investigators, patients, and CROs, study coordinators play a crucial role in alleviating many of the pain points experienced by CROs in clinical trials. For example, in terms of site management, professional CRCs are responsible for implementing standardized processes at the site-level, ensuring consistent protocol compliance, regulatory and ethical compliance in daily operations, and managing site-specific challenges. This standardization is crucial for CROs in maintaining data quality and regulatory compliance across diverse study locations.  

Another common pain point of CROs is maintaining proper data integrity within electronic data capture (EDC) systems, which is where study coordinators come in. They are the primary contact for CROs to assist in resolving data queries on time, reducing the backlog of data clarifications that often plague CROs, particularly close to interim analysis deadlines.  

Because study coordinators are on the ground and have direct relationships with patients and site staff, they are in an ideal position to address issues quickly, preventing delays in data lock and analysis. Interestingly, an experienced study coordinator can also contribute to resource optimization for CROs because their role enables them to take on tasks that would otherwise require multiple specialized roles, helping streamline operations and reduce personnel costs. There are no shortages of challenges that accompany clinical trials for CROs and CRCs provide valuable assistance across several more areas. Read about the top 10 pain points in clinical trials here that study coordinators alleviate for CROs. 

For more details, download our white paper here to learn how you can leverage the expertise of a study coordinator to improve efficiency and compliance in your next clinical trial. 

 

3. The Crucial Role of CRCs in Navigating Complex Regulatory Requirements

TFS’s Strategic Study Coordination campaign highlighted the key role of CRCs in helping sponsors and CROs remain compliant with various regulatory bodies like the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and more, each with its own set of guidelines and requirements. For example, in the case of a new protocol amendment, CRCs must facilitate clear communication between regional teams, investigators, and central trial management to help ensure their consistent implementation. Furthermore, as a research site’s team expands, senior study coordinators are often responsible for guiding new through standardized training and education in accordance with GCP and other regulatory guidelines.  

Want to learn more? Read the 7 Ways Study Coordinators Help Navigate Complex Regulation here. 

 

4. Study Coordinators are Crucial for Improving Recruitment and Patient Experience

Chaudhari et al. (2020) reported that participant recruitment takes up to 30% of trial development timelines, and can involve costs of over US$1 billion. Failure to meet enrollment targets and timelines are one of the most common problems in clinical trials, with the resulting delays costing the pharmaceutical industry between US$600,000 and US$8 million for each day of delay. With 11% of clinical research sites failing to enroll even a single participant, leveraging the experience of study coordinators is crucial for setting up effective recruitment strategies. The recruitment process is plagued with several challenges, including lack of awareness about clinical trials, patient sociocultural issues, and fears or misinformation about the risks involved with clinical study participation.  

Study coordinators are well-positioned to address these challenges. For example, at the site selection stage, professional CRCs work with PIs to complete robust feasibility analyses and successfully lead site qualification visits with expertise. This results in more appropriate site selection prior to study start, which is a key strategy for meeting recruitment timelines, because sponsors can be appropriately informed about the recruitment capabilities of the site early on. Other important recruitment contributions from CRCs include following up with potential participants and implementing data mining strategies to identify new patients for enrollment. Furthermore, because study coordinators serve as the primary point of contact for participants, providing education and offering support throughout the study, they can establish a strong long-term rapport with patients to improve their trial experience and foster greater feelings of trust in the site team. 

 

5. SRS and FSP Services Offer Additional Benefits with Strategic Study Coordination

Finally, TFS’s Strategic Study Coordination campaign highlighted the benefits of combining study coordination with strategic resourcing solutions (SRS) and functional service provider (FSP) services. In particular, TFS is one of the largest mid-sized FSPs with a global network of 70,000 CRPs and over 15 years of experience providing SRS and FSP services. Utilized by more than 30 well-known life science companies across 26 countries, these targeted solutions assist sponsors, investigators, and even other CROs with resourcing and building the right CRCs for their unique clinical trial needs. Because TFS’s SRS team already has the required resources, infrastructure, and expertise, they can support strategic study coordination by granting requests for study coordinator onboarding and placements with efficiency. In combination with these services, their FSP model makes them a reliable outsourcing partner that can be deployed to provide cost-effective support in roles like CRCs and nurses. Click here to learn more about TFS’s SRS capabilities. 

In this article, TFS CRO discusses how organizations can benefit from SRS and FSP services. These insights suggest strategic study coordination can provide sponsors and CROs several advantages: 

1. Enhanced recruitment and retention with customized recruitment plans and access to a wider pool of potential participants through extended networks. 
2. Greater flexibility and scalability by leveraging efficient SRS capabilities to recruit CRCs with specialized expertise for specific trial phases or procedures. 
3. Improved regulatory compliance with their access to study coordinators well-versed in global and local regulatory requirements.  
4. Enhanced data management and quality from relying on FSP-based outsourcing to streamline processes for data cleaning, validation, and reporting. 
5. Greater cost savings from more efficient resource allocation, including optimizing project staffing assignments, to cater to a trial’s specific needs at any given time. 

Read the full article here! 

Interested in taking advantage of FSP business models to navigate challenges in your next clinical trial? Download our white paper detailing several Innovative FSP Solutions for Biopharma Growth & Transmission or watch our informative webinar here.  

 

TFS’s July Poll Series: Insights into Key Challenges and Priorities of Study Coordinators  

TFS conducted a series of July polls to gain valuable insights into the challenges and priorities of study coordinators and site staff in clinical trials.  

Here are some key insights and actions from TFS’s July Poll Series:

• Addressing Patient Recruitment Challenges: With over 50% of respondents identifying “Patient Recruitment” as the biggest hurdle, it’s clear that finding eligible patients remains a top concern. TFS Study Coordinators can help mitigate this challenge by leveraging targeted recruitment strategies, streamlining multi-site coordination, and fostering stronger partnerships with sites to optimize recruitment outcomes.
• Enhancing Data Management Support: Data management was highlighted as another significant issue by nearly 30% of participants. TFS Study Coordinators are equipped to assist with efficient data entry, real-time monitoring, and ensuring data accuracy, alleviating the pressure on sites.
• Increasing Focus on Patient Engagement: With “Enhancing Patient Engagement” as the most critical skill identified, TFS Coordinators can focus on improving the patient experience, retention, and engagement through personalized communication and patient-centric approaches. This ensures that studies not only meet recruitment goals but also retain participants through completion.
• Ensuring Regulatory Compliance: Regulatory compliance was a top priority for over 20% of respondents. TFS Study Coordinators can proactively support sites by staying ahead of regulatory requirements, ensuring thorough compliance at every phase of the trial, and guiding teams through complex audits and inspections.

These insights reinforce TFS’s dedication to understanding and addressing the key pain points within study and site coordination, empowering sites with the right tools and expertise to enhance study outcomes.

See the full poll responses below:  

1. Biggest Challenges in Study and Site Coordination: “Patient Recruitment” (50.5% of respondents) was the most commonly identified challenge, followed by “Data Management” (27.3%) and “Regulatory Compliance” (20.2%). 
2. Most Demanding Aspect of Recruitment Process: “Finding Eligible Patients” (55% of respondents) was overwhelmingly identified as the most demanding part, followed by “Coordinating Multi-Site Tasks” (17.5%), “Ensuring Patient Retention” (15.0%), and “Regulatory Requirements” (12.5%). 
3. Critical Skills for Study Coordinators: “Enhancing Patient Engagement” (34.9% of respondents) was identified as the most important skill, followed by “Using Digital Tools” (25.4%) and “Navigating Regulatory Changes” (23.8%). 
4. Most Valued Regulatory Task for Study Coordinators: “Ensuring Site Compliance” (69.8% of respondents) was by far the most valued regulatory task, followed by “Monitoring Regulatory Updates” (15.1%),  “Handling Audits & Inspections” (9.4%), and “Submitting Regulatory Docs” (5.7%). 

 

Key Advantages of Partnering with TFS CRO for Strategic Study Coordination Services 

Recognizing the above challenges and priorities of study coordinators, TFS’s strategic study coordination services offer several benefits. Most importantly, their SRS and FSP divisions ensure sponsors receive customized solutions tailored to each trial’s unique challenges, allowing for proactive issue resolution and keeping trials on track. In addition to regulatory expertise, TFS study coordinators offer extensive operational and scientific expertise to reduce non-compliance risks and strategically improve trial management efficiency at the site-level. CRCs sourced by TFS’s SRS team are also screened for their knowledge of effective patient recruitment and retention strategies to maintain engagement throughout a trial’s lifecycle. Lastly, strategic study coordination supports greater collaboration between organizations and promotes more effective communication between study coordinators and other key stakeholders. In fact, the following case study describes how TFS was able to overcome barriers in a challenging oncology-hematology clinical trial by utilizing SRS-based study coordination.  

 

TFS Case Study: SRS-Based Study Coordinator Engagement Rescues an Oncology Trial 

TFS was recently brought on to rescue a struggling Phase III oncology-hematology clinical trial through their SRS approach. The sponsor identified three key problems in the trial involving data management issues, communication breakdowns, and trial efficiency concerns. After resourcing and engaging a highly qualified study coordinator who passed their rigorous selection process, TFS was able to address each problem area with the following targeted solutions: 

1. The study coordinator ensured data was captured accurately and securely by maintaining sound source documentation practices, while regularly updating the trial database. 
2. The study coordinator kept track of the study cycle and participant follow-up visits and worked towards reducing participant burden. 
3. The TFS study coordinator responded to many accumulated queries, then strengthened communication between the research staff and the sponsor. 

As a result of these solutions implemented by TFS, each of the sponsor’s challenges was clarified, understood, and addressed. This collaboration ended with several positive outcomes, including an up-to-date trial database, well-managed patient visits and greater patient engagement, as well as clearer channels of communication. Read about the full details of this case study and TFS’s SRS-based study coordination strategies here. 

Get started with TFS’s Strategic Study Coordination Services here and experience the difference that professional study coordinators can make in your clinical trials. 

 

Conclusion 

In conclusion, TFS highlighted several key insights into the critical role of effective study coordination in modern clinical trials, as well as their primary challenges and priorities. To address common challenges faced by sponsors today, with the increasing complexity of clinical trials, TFS offers comprehensive tailored solutions through their SRS and FSP services. With the integration of these approaches in trial management processes, organizations can benefit from the advantages of strategic study coordination, including improved flexibility, regulatory compliance, and cost efficiency. As demonstrated by our case study, partnering with professional CRCs resourced by experienced organizations like TFS can significantly improve trial outcomes and streamline processes to achieve greater success in clinical drug development. 

 

TFS CRO: An Industry Leader in SRS and FSP Services 

At TFS HealthScience, we offer a 100% dedicated team to support biotechnology and pharmaceutical companies throughout their entire clinical development journey. As a leading mid-sized CRO with a global presence across 16 countries, our customized approach is underscored by a deep commitment to understanding our clients’ needs set us apart. Our SRS and FSP services have been a trusted component throughout the entire clinical development journey since 1996 and our strategic resourcing experts possess a long-standing history of successful recruitment of CRPs for our clients. Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!