White Papers

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Agentic AI And How It's Impacting Clinical Trial Research 7/7/2025

    Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.

  8. Powering More Efficient Clinical Development With AI And ML 7/7/2025

    Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.

  9. Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps 7/7/2025

    Modernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.

  10. eSource Purpose Is Not Just To Complete The EDC 7/7/2025

    Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.