Insights on Clinical Trials

  1. How To Build Effective Clinical Trial Oversight And Leadership 7/14/2025

    In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

  2. Writing Effective Clinical Regulatory Documents For Therapy Trials 7/11/2025

    Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

  3. Adaptive By Nature: Modern Tools For Modern Trial Designs 7/10/2025

    Adaptive platform trials (APTs) are reshaping clinical research by enabling multiple therapies to be tested simultaneously under a single, flexible protocol.

  4. New EDC Tools Enable Even Faster Self-Serve Study Builds 7/10/2025

    Explore a powerful yet accessible EDC solution that enables faster, more efficient study builds without compromising data integrity or compliance, allowing clinical teams to focus on advancing research outcomes.

  5. Streamline Recruitment With Confidence 7/10/2025

    Transform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.

  6. Immunology's Next Frontier: High-Risk, High-Reward Innovations From EULAR 2025 7/10/2025

    The 2025 European Congress of Rheumatology (EULAR) showcased a shift in immunology, highlighting a convergence of next-generation mechanisms and novel therapeutic modalities. Of note is the emergence of cell therapies as a treatment strategy.

  7. Leveraging Biomarkers In Early PK/PD Studies 7/9/2025

    Integrating biomarkers into early clinical studies is crucial to determine whether a new therapy engages its biological target, triggers the intended PD effects, and shows early signs of efficacy.

  8. 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.

  9. CMC Strategies For Cell And Gene Therapy Development 7/2/2025

    The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

  10. Project Optimus: Shifting Away From Maximum Tolerated Dose 7/2/2025

    Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.