Regulatory Insights

  1. The Clinical Trial Rescue Triage Playbook 1/15/2026

    Quickly assess clinical trial risks by evaluating site impact, patient safety, and budget tradeoffs. Turn high-pressure rescue scenarios into clear, actionable paths for your research team.

  2. No More Swiss Holes: Filling The Gaps In Clinical Trial Disclosure 1/14/2026

    This use case shows how sponsors can gain clarity on disclosure requirements when entering a new country.

  3. Designing The Path: Strategic Planning To Maximize Biotech Appeal 1/14/2026

    Aligning clinical, regulatory, and operational strategies boosts biotech investment appeal. Strategic planning, clear milestones, and risk mitigation accelerate development and attract funding.

  4. Crafting The Vision: Building A Strong Value Story For Biotechs 1/14/2026

    Early-stage biotechs need more than science — they need a clear vision. Learn to craft a value story that shows differentiation, market potential, and patient impact to attract investors and partners.

  5. FDA Pushes For Patient Voice: ePRO In Oncology Trials 1/8/2026

    FDA urges sponsors and CROs to include patient voices in oncology trials. Discover why it matters and how to start integrating this approach.

  6. 6 Key Implications Of EU Clinical Trials Regulation 1/7/2026

    Centralized submissions, greater transparency, and stronger patient protections reshape EU clinical trials, impacting timelines, costs, and strategies for sponsors and CROs.

  7. A New, AI-Augmented Horizon For Safety And Pharmacovigilance 1/6/2026

    Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.

  8. Psychiatric Drug Development Renaissance: With Familiar Risks 1/6/2026

    Emerging psychiatric therapies bring hope, but progress is fragile. Biomarker-driven, mechanism-first approaches help overcome biological, regulatory, and commercial barriers.

  9. Clinical Research Trends And IRB Expectations For 2026 1/6/2026

    Oversight in 2026 requires adaptability as AI, consent standards, and regulatory uncertainty challenge sponsors and IRBs to balance ethics with innovation through proactive planning and collaboration.

  10. Why Early Medical Assessment Matters In Clinical Trials 1/6/2026

    Early medical assessment reduces risk, improves patient selection, and avoids trial delays. Learn how starting early boosts compliance, speeds timelines, and protects participants and results.