White Papers

  1. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

    As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

  2. Demanding More From AI Governance In Drug Safety 8/13/2025

    Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

  3. 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.

  4. 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

  5. Potential Of eClinical Solutions To The Complexity Of Oncology Trials 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.