White paper Archives - TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO

Early-Phase Oncology Study Start-Up in Today’s Clinical Environment

Diana — Thu, 07 Nov 2024 20:38:08 +0000

Early-Phase Oncology Study Start-Up in Today’s Clinical Environment

Explore the latest advancements in oncology research and discover innovative strategies for overcoming the complexities of cancer trials. This white paper highlights best practices in Early-Phase Oncology Study Start-Up site selection, adaptive trial design, contract negotiations, and patient enrollment to accelerate study start-up and improve efficiency in early-phase cancer trials. Learn how partnering with an Oncology contract research organization (CRO) can optimize oncology studies while prioritizing patient safety and data integrity.

Download our white paper to discover how:

The growing complexity of oncology clinical trials, driven by advancements in biomarkers and immunotherapies, requires adaptive or seamless trial designs.
Effective site selection and the right choice of vendors play a pivotal role in speeding up study start-up.
Tailoring patient selection criteria and optimizing enrollment strategies are critical in early-phase oncology trials.
Leveraging the expertise of an oncology cro allows sponsors to conduct trials more efficiently and with high ethical standards.

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Case Study

Advancing Immunotherapy TFS Supports a CAR T-Cell Therapy Study in Hematologic Malignancies

Advancing CAR T-cell therapy in hematologic malignancies highlights innovations in immunotherapy and cancer treatment.

Case Study

Optimizing Early-Stage Oncology: TFS’s Strategic Approach to a Dose Escalation and Expansion Phase I Trial

Explore how a U.S. biotech partnered with a CRO to manage a Phase I oncology trial for advanced epithelial tumors.

Case Study

TFS Drives Early-Phase Success in Advanced Solid Tumors Study

Discover TFS's role in achieving early-phase oncology success for a European biotech targeting advanced solid tumors.

The post Early-Phase Oncology Study Start-Up in Today’s Clinical Environment appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Harnessing Real-World Evidence (RWE) for Effective External Control Arms in Clinical Trials

Diana — Thu, 24 Oct 2024 19:22:38 +0000

Harnessing Real-World Evidence (RWE) for Effective External Control Arms in Clinical Trials

Explore the growing role of real-world evidence (RWE) in constructing external control arms for clinical trials, especially when traditional randomized controlled trials (RCTs) face practical or ethical constraints. This white paper highlights the complexity of modern trials in fields like oncology and rare diseases, the operational challenges, and how RWE—sourced from electronic health records, patient registries, and claims—provides valuable comparators. The paper also discusses regulatory guidelines, statistical methods for reducing bias, and the importance of partnerships with contract research organizations (CROs).

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How real-world evidence offers an effective alternative for external control arms when RCTs are not feasible
When complexity in trials, such as rare diseases and oncology trials, drive RWE adoption
Regulatory Support by the FDA and EMA provide guidelines for its appropriate use
Why strategic partnerships and collaboration with CROs are essential for successfully integrating RWE into external control arms

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Case Study

From Challenge to Victory: TFS’s RWE EMA Success Story with a Pivotal Retrospective Study

Delve into how TFS leveraged vast US real-world data to secure EMA approval for an extended-release CNS drug, bypassing traditional costly trials.

Case Study

Shaping Success: TFS Tackles RWE for a Line Extension in Newborn Respiratory Rarity

Discover how TFS harnessed the power of Real-World Evidence (RWE) to transform a high-stakes clinical trial into a groundbreaking respiratory treatment in newborns.

Webinars

Future of Real-World Evidence: Common Data Models and OHDSI Tools Used in the COVID-Real Case Study

Explore the future of Real-World Evidence (RWE) in clinical research with insights on Common Data Models and OHDSI tools from TFS and IOMED.

The post Harnessing Real-World Evidence (RWE) for Effective External Control Arms in Clinical Trials appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Maximizing Efficiency: A Comprehensive Guide to Study Coordination Services

Jessica — Thu, 25 Jul 2024 20:53:23 +0000

Maximizing Efficiency: A Comprehensive Guide to Study Coordination Services

Efficient study coordination is the backbone of successful clinical trials, ensuring adherence to regulatory standards, participant safety, and data integrity. This white paper explores the pivotal role of study coordinators, outlining the skills, competencies, and strategic value they bring to clinical research. By leveraging the expertise of study coordinators, organizations can navigate the complexities of clinical trials with greater efficiency and compliance, ultimately leading to high-quality outcomes and advancements in medical research.

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The essential role and responsibilities of Study Coordinators in clinical trials.
Key competencies and skills required for effective study coordination.
Strategies for enhancing efficiency and compliance in clinical trial management.
The impact of study coordinators on participant recruitment, retention, and overall trial success.

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Article

Why Investigators Need a Study Coordinator

Explore why study coordinators are essential for efficient, ethical, and compliant clinical trials, boosting overall success of the study.

Infographic

Infographic: Effective Study Coordination: A Roadmap to Successful Clinical Trials

Explore how study coordination guides clinical trials to success, ensuring efficiency, compliance, and high-quality outcomes at every stage.

White paper

Maximizing Efficiency: A Comprehensive Guide to Study Coordination Services

Explore the pivotal role of study coordinators in clinical trials and learn how their expertise enhances efficiency, compliance, and participant safety. Download the white paper to gain insights into effective…

The post Maximizing Efficiency: A Comprehensive Guide to Study Coordination Services appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Innovative FSP Solutions for Biopharma Growth & Transition

Jessica — Thu, 13 Jun 2024 14:38:33 +0000

Innovative FSP Solutions for Biopharma Growth & Transition

Explore our latest white paper on “Innovative Functional Service Provider (FSP) Solutions for Biopharma Growth & Transition,” which details how FSP models are revolutionizing the pharmaceutical industry. By integrating specialized functions and leveraging advanced technologies like AI and big data analytics, FSP models streamline operations, reduce costs, and accelerate the time-to-market for new therapies.

The paper highlights the strategic importance of effective team dynamics, clear communication, and innovative talent acquisition in achieving peak performance. Case studies, such as the collaboration between a leading pharmaceutical company and TFS in Portugal, illustrate the benefits of FSP models in driving success through strategic team structures and transparent communication.

By focusing on strategic alignment and resource optimization, FSP models enable biopharma companies to adapt to market dynamics and capitalize on emerging opportunities. Embracing FSP models can significantly benefit the industry by enhancing efficiency and fostering growth.

Stay informed about ongoing strategic resourcing solutions (SRS) and promising advancements, shaping the future of clinical research.

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Challenges and opportunities with resourcing
How to leverage FSP business models
Strategies for team performance improvements
How to enhance client relationships and communication
Innovative strategies for talent aquisition and retention
Review a case study on TFS’s FSP solutions

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Article

5 Predictions for the Biopharma and Biotech Industries in 2025

Dive into trends & innovations set to shape the industry, including advances in precision medicine, clinical trial designs, and AI innovation.

Article

10 Key Questions to Ask Your CRO to Ensure Your Clinical Trial’s Success

Discover the 10 essential questions to ask your CRO on how to assess expertise, timelines, communication, and more for optimal trial outcomes.

Article

Building a High-Performance Team: Key Considerations for Clinical Trial Talent Acquisition

Discover strategies for building high-performance teams in clinical trials, including talent acquisition trends and management practices.

The post Innovative FSP Solutions for Biopharma Growth & Transition appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Challenges and Considerations for Gene Therapy Trials for Inherited Retinal Diseases (IRDs)

Jessica — Fri, 07 Jun 2024 14:23:49 +0000

Challenges and Considerations for Gene Therapy Trials for Inherited Retinal Diseases (IRDs)

Explore our latest white paper on the advancements in gene therapy for inherited retinal diseases (IRDs). In it, we discuss the genetic basis of IRDs and current therapeutic strategies like gene augmentation, CRISPR/Cas9, and optogenetics. This white paper also discusses the importance of robust clinical trial designs, emphasizes patient-centered approaches and ethical considerations, and outlines the challenges and future prospects in developing effective treatments for these vision-impairing conditions.

Stay informed about ongoing ophthalmology clinical trials and promising advancements, shaping the future of ophthalmic care.

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Technical advances in gene therapy methods
Clinical trial frameworks for gene therapy in IRDs
The landscape of gene therapy in IRDS clinical trials
Patient-centered perspectives in IRD clinical trials

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Article

Updates in the Ophthalmology Clinical Landscape

Explore new treatments, innovations, and advancements in eye care that are shaping the future of ophthalmology.

Article

Empowering the Visually Impaired: Assistive Technologies and Education

See how assistive technologies and education are empowering the visually impaired, enhancing accessibility, independence, & quality of life.

Article

Top 10 Insights from Euretina 2024

Explore the top 10 insights from Euretina 2024, highlighting breakthroughs in retinal research, clinical practices, and ophthalmology innovations.

The post Challenges and Considerations for Gene Therapy Trials for Inherited Retinal Diseases (IRDs) appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Navigating the Evolving Landscape of Immunotherapy in Oncology: Insights from Recent Advancements and Approvals

Jessica — Tue, 28 May 2024 18:49:17 +0000

Navigating the Evolving Landscape of Immunotherapy in Oncology: Insights from Recent Advancements and Approvals

Explore our latest white paper on the evolving landscape of immunotherapy in oncology, where we discuss the significant advancements and regulatory approvals shaping new therapeutic paradigms. Key points include the expanded use of immune checkpoint inhibitors (ICIs) such as toripalimab and tremelimumab, which have become frontline treatments for various cancers. We also highlight the remarkable progress in other immunotherapy modalities, including CAR-T and TCR-T cell therapies, personalized cancer vaccines driven by mRNA technologies, and multi-specific antibodies. Additionally, the paper covers the global approval of oncolytic viral (OV) therapies, which selectively target and kill cancer cells. We address the impact and challenges of immunotherapy, including resistance to treatments and immune-related adverse events, and discuss the potential for new clinical trial strategies to further revolutionize cancer care.

Stay informed about ongoing oncology clinical trials and promising advancements, shaping the future of oncological care.

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Regulatory approvals of immuno-oncology therapies
The landscape of immune checkpoint inhibitors (ICIs)
Advances in other immunotherapy modalities
Approved oncolytic viral (OV) therapies
Impact, challenges, and future directions of immunotherapy

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Article

Top Contract Research Organizations for Oncology in 2025

Learn how these top CROs are advancing cancer research with innovative trial designs, specialized expertise, and cutting-edge technology.

Article

Top 10 Contract Research Organizations (CROs) in 2025

Discover the top 10 CROs in 2025. Learn about industry leaders in clinical trials, technology adoption, & global healthcare solutions.

Case Study

Optimizing Early-Stage Oncology: TFS’s Strategic Approach to a Dose Escalation and Expansion Phase I Trial

Explore how a U.S. biotech partnered with a CRO to manage a Phase I oncology trial for advanced epithelial tumors.

The post Navigating the Evolving Landscape of Immunotherapy in Oncology: Insights from Recent Advancements and Approvals appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Understanding Neurological Clinical Trial Trends for 2024

Jessica — Wed, 08 May 2024 17:38:35 +0000

Understanding Neurological Clinical Trial Trends for 2024

Explore our latest white paper on neurological clinical trial trends for 2024 and beyond. The current landscape of neurological clinical trials focuses on trends and challenges in drug development for conditions like Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis (MS). This white paper highlights the complexities faced in trial design, patient recruitment, and data collection due to factors like disease heterogeneity and the need for more precise biomarkers. As well as explores emerging strategies such as the integration of neuroimaging techniques, utilization of novel fluid biomarkers, and the application of artificial intelligence (AI) and machine learning (ML) in data analysis. Additionally, it discusses the evolving trend towards decentralized clinical trials (DCTs) and the integration of digital health technologies to improve patient access, diversity, and retention in trials. The regulatory and ethical considerations surrounding these advancements are also addressed, emphasizing the need for patient-centric approaches while ensuring data integrity and participant safety.

Stay informed about ongoing neurological clinical trials and promising advancements, shaping the future of neurological care.

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Emerging trends in neurological clinical trial methodologies.
The role of innovative biomarkers and neuroimaging techniques in drug development.
Advancements in digital health technologies and decentralized trial approaches.
Regulatory and ethical considerations for integrating digital and AI technologies.
Strategies for optimizing patient recruitment, retention, and data quality in neuroscience research.

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Article

Top 10 Contract Research Organizations (CROs) in 2025

Discover the top 10 CROs in 2025. Learn about industry leaders in clinical trials, technology adoption, & global healthcare solutions.

Article

Top 10 Advances in Alzheimer’s Research

Explore the top 10 recent advances in Alzheimer's research, including new treatments, diagnostic tools, and promising studies that offer hope for early detection and disease management.

Webinars

Accelerating Neurodegenerative Clinical Drug Development with AI

Watch our webinar to gain insights on how AI is playing a crucial role in advancing CNS research related to neurodegenerative clinical drug development.

The post Understanding Neurological Clinical Trial Trends for 2024 appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Emerging Trends in Dermatological Research in 2024

Jessica — Wed, 01 May 2024 19:50:49 +0000

Emerging Trends in Dermatological Research in 2024

Explore our latest white paper on the emerging trends and future directions in dermatological research for 2024 and beyond. Dermatology research is poised to witness transformation in the coming years, driven by innovations in high throughput technologies, systems biology, and artificial intelligence (AI). The development of new biologic drugs and immunotherapies has revolutionized patient care across dermatology therapeutic areas, including oncology, auto-immune disorders, and genetic disorders, by offering treatments with increased accuracy and fewer side effects.

Stay informed about ongoing dermatology clinical trials and promising advancements, shaping the future of dermatological care.

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Omics studies & precision medicine in dermatological research.
The role of artificial intelligence & machine learning in dermatological research.
Innovations in drug modalities.
Nanotechnology in dermatology.
The future directions of dermatological research.

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We have the right people and right solutions to help you on your path to success. Let’s talk today.

The post Emerging Trends in Dermatological Research in 2024 appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

Epidermolysis Bullosa: Future Perspectives in Drug Development

TFS Marketing — Mon, 01 Apr 2024 17:50:20 +0000

Epidermolysis Bullosa: Future Perspectives in Drug Development

Explore our latest white paper on Epidermolysis Bullosa (EB) and its future prospects in drug development. EB is a heterogeneous group of rare disorders characterized by mechanical fragility of epithelial tissues. Researchers around the globe are investigating new therapies to improve the quality of life of patients with little or even non-available therapeutic options so far, particularly for the more severe variants. New horizons could be opened in the coming years in one of the ”Worst Disease You’ve Never Heard Of,” according to DEBRA (Dystrophic Epidermolysis Bullosa Research Association of America).

Stay informed about ongoing clinical trials and promising advancements, shaping the future of EB treatment.

Download our white paper to discover:

Insights into the genetic complexities and clinical heterogeneity of EB.
Current classification systems and diagnostic techniques for accurate EB diagnosis.
Cutting-edge therapies, including gene therapy and protein therapy, shaping the future of EB management.
Ongoing clinical trials and promising advancements driving innovation in EB treatment.

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TFS Dermatology

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We have the right people and right solutions to help you on your path to success. Let’s talk today.

The post Epidermolysis Bullosa: Future Perspectives in Drug Development appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.

A Survey of Approved PD1/PD-L1 Immune Checkpoint Inhibitors Landscape in the United States and Europe

Emma — Fri, 02 Feb 2024 03:15:13 +0000

A Survey of Approved PD1/PD-L1 Immune Checkpoint Inhibitors Landscape in the United States and Europe

Embark on a detailed exploration of the landscape of PD1/PD-L1 immune checkpoint inhibitors in the United States and Europe. This comprehensive guide provides invaluable insights for sponsors looking to design effective clinical trials in oncology and formulate strategic early development plans.

This white paper explores the transformative impact of PD1/PD-L1 immune checkpoint inhibitors across a range of solid tumors, gaining a deeper understanding of FDA and EMA-approved indications.

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Strengths of PD1/PD-L1 inhibitors across diverse cancers, understanding their mechanisms and citing successful clinical outcomes.
Challenges and limitations, including immune-related adverse events and resistance issues.
Future potential of combining immune checkpoint inhibitors with other anti-cancer agents, drawing on data from current clinical studies and trials.

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TFS Oncology & Hematology

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We have the right people and right solutions to help you on your path to success. Let’s talk today.

The post A Survey of Approved PD1/PD-L1 Immune Checkpoint Inhibitors Landscape in the United States and Europe appeared first on TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO.