Insights on Clinical Trials

  1. Clinical Research Update: The New FDA Form 1572 is Available 3/5/2026

    Stay current with the latest FDA investigator filing updates. Learn when to transition to the new version and how to maintain compliance without unnecessary administrative re-work.

  2. FDA Updates Guidance For Written IRB Policies 3/5/2026

    Explore how updated FDA and HHS guidance harmonizes regulations, streamlines IRB operations, and strengthens oversight for complex clinical trials.

  3. Tailored Approach Supports Bladder Cancer Breakthrough 3/5/2026

    Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.

  4. Challenges That Derail Bladder Cancer Trials And How To Anticipate Them Earlier 3/5/2026

    From the rapid evolution of standard-of-care benchmarks to the logistical strain of procedure-heavy urology workflows, the path to a successful endpoint is filled with operational friction.

  5. Inside The Payer Perspective On Cell And Gene Therapy Coverage 3/2/2026

    Find out what 19 US payer organizations revealed about CGT coverage decisions, pre-approval engagement timelines, and the clinical evidence they need most to approve high-cost therapies.

  6. 21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us? 2/23/2026

    Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.

  7. Best Practices For Managing The Logistics And Distribution Of CGTs 2/23/2026

    Site infrastructure, formulary timelines, and storage capabilities create barriers between approval and patient access. Planning for these operational realities separates successful launches from stalled ones.

  8. Breaking Through Tumor Defenses With Next-Generation Cell Therapy 2/20/2026

    Ernexa Therapeutics CEO Sanjeev Luther shares how clinical research has revealed why certain cancers resist treatment and how emerging cell therapies may help break through those defenses.

  9. Develop A Comprehensive Strategy For Implementing AI & Multi-Omics 2/19/2026

    Discover how a strategy-first approach to AI and multi-omics transforms complex biological data into actionable clinical decisions and more precise, targeted oncology therapies for 2026 and beyond.

  10. Scaling Success: A Blueprint For Flexible Biometrics Partnerships 2/19/2026

    Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.