White Papers

  1. The Strategic Advantage Of eCOA And IRT 8/11/2025

    The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.

  2. Rewriting The Future Of Clinical Trials 8/8/2025

    In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development

  3. Insights Into The Potential Of eClinical Solutions 7/31/2025

    How are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.

  4. In-Vivo CAR Therapies — Global Research And Development Landscape 7/15/2025

    Delve into the evolving in-vivo CAR therapy landscape, examining key technological innovations, major industry players, recent clinical progress, and regulatory developments.

  5. Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress 7/15/2025

    Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

  6. A New Approach To Dynamic Clinical Oversight With Centralized Insights 7/10/2025

    RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.

  7. RWD, New Technologies Show Potential In Clinical Trial Recruitment 7/10/2025

    Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.

  8. Sickle Cell Cure Within Reach, But At A Steep Cost 7/10/2025

    Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.

  9. Leveraging Real-World Data From The IRIS® Registry 7/8/2025

    With the FDA’s new Diversity Action Plan requirements, sponsors are now expected to set clear goals and strategies for enrolling diverse populations in clinical trials.

  10. Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry 7/8/2025

    Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.