Featured Articles

  1. Biotech Delivers A Superior Patient And Site Experience 3/4/2025

    To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

  2. Everest Group Life Sciences EDC Products PEAK Matrix® Assessment 2024 2/11/2025

    This Everest Group report examines Medidata’s Rave EDC and its impact on the clinical development value chain of life sciences.

  3. eCOA 101: What Is Electronic Clinical Outcome Assessment? 2/11/2025

    Electronic Clinical Outcome Assessment (eCOA) has transformed data collection in clinical trials by prioritizing patient engagement and improving data accuracy.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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 FDA Draft Guidance On Diversity Action Plan Requirements 10/24/2024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