Featured Articles

  1. Understanding The New FDA Guidance On Decentralized Clinical Trials 2/11/2025

    Explore the evolution of the FDA decentralized clinical trial (DCT) guidance, highlighting key updates on responsibilities, data variability, inspections, and trial design.

  2. What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research? 1/28/2025

    Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.

  3. RBQM: The Connective Tissue For Data Quality 1/13/2025

    RBQM integrates data-driven processes into clinical trials, ensuring enhanced quality and operational efficiency while emphasizing the synergy between QBD principles and robust data systems.

  4. How Syneos Health Tackles Protocol Complexities 1/7/2025

    Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase IIV clinical trials, particularly under a complex adaptive trial protocol.

  5. The Changing Landscape Of Clinical Monitoring 11/20/2024

    Medidata recently commissioned an independent industry survey to understand the current landscape for clinical monitoring modalities and expectations for the future.

  6. The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality 11/18/2024

    Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.

  7. FDA Draft Guidance On Diversity Action Plan Requirements 10/24/2024

    Explore new drafted guidance under FDORA that substantiates the mandate of a Diversity Action Plan (DAP) for late-stage trial protocol submissions.

  8. A Guide To Patient Reimbursements And Payments 9/13/2024

    Delayed or inadequate payments can harm patient retention and site efficiency. Learn how sponsors can mitigate financial toxicity, streamline reimbursement, and ensure a positive experience for all involved.

  9. Challenges And New Approaches To Developing Clinical Evidence For Medical Devices 9/12/2024

    Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.

  10. Cracking The Code: Strategies For Success In Complex Trials 8/27/2024

    Navigating the complexities of modern clinical trials requires advanced technology and strategic planning. Learn what goes into managing a challenging, decentralized rare disease trial.