White Papers

  1. 2025 Safety And Regulatory Compliance Trends And Predictions 12/16/2024

    Explore the rapidly evolving regulatory landscape that pharmaceutical and biotech industries face as they integrate AI and advanced technologies into safety, compliance, and lifecycle management.

  2. Ensuring A Diverse Patient Population In Clinical Trials 12/13/2024

    In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.

  3. Vaccine Clinical Trials Global Landscape Whitepaper (2024) 12/5/2024

    The global vaccine trial landscape is undergoing rapid evolution, driven by technological innovations, emerging health threats, and regulatory shifts.

  4. 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.

  5. Preparing CRAs For Success In Oncology: Targeted Training In An Era Of Advanced Therapeutics 11/18/2024

    Explore the pivotal role of Clinical Research Associates (CRAs) in oncology clinical trials, emphasizing their critical responsibilities and the importance of specialized CRA training programs.

  6. Patient Diaries Done Right: A Blueprint For Success 11/18/2024

    Discover how patient diaries can improve data quality and engagement, as well as best practices to design, deploy, and monitor diaries that work for both participants and researchers.

  7. Bladder Cancer Global Clinical Trial Landscape (2024) 11/12/2024

    Bladder cancer is the ninth most common cancer in the world and thirteenth in mortality. This report provides a detailed overview of the clinical trial landscape for bladder cancer.

  8. Practical Strategies For Diverse Trial Recruitment 11/11/2024

    The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.

  9. The Rapid Digitization Of Trials 11/7/2024

    It’s no secret that more trials are going digital. Hear from a panel of industry experts including Sanofi, Bayer, and the Clinical Trials Transformation Initiative (CTTI) as they discuss the evolution of digital trials and share their experiences.

  10. The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting 10/30/2024

    The twin pressures of inflation and attrition prolong negotiations between sponsors and clinical sites, stalling drug development. Sponsors need up-to-date, reliable benchmark data to negotiate fair market value budgets.