Regulatory Insights

1. How Sponsors Are Responding To FDA's RTCT Request For Information 9/9/2026

   Let's take a look at where continuous, real-time regulatory review can meaningfully speed drug development, and where it likely won't help much.

2. Cross-Functional Best Practices For Signal Detection In Special Case Scenarios 9/7/2026

   When trial data fall short, real risk signals surface in inquiries, complaints, and reports. Learn how coordinated, cross-functional practices help catch risk earlier.

3. Strategic ADC Development In A Shifting Regulatory Landscape 8/28/2026

   As ADC development grows more complex, sponsors must align safety, dose optimization, global trial design, regulatory strategy and CMC readiness early to reduce risk and accelerate approval.

4. The Rise Of Chinese Biotechs And The Global CRO Question 8/25/2026

   As innovative therapies move beyond home markets, early planning across regulators and geographies helps avoid costly delays and protect trial budgets.

5. How Modern Logistics Support Belmont And HHS OIG Goals 8/24/2026

   Participant support can expand trial access, but regulatory uncertainty limits adoption. A safe harbor could enable reimbursement and compensation while protecting against coercion and undue influence.

6. Psychedelic Drug Trials: Are Your Sites Ready? 8/24/2026

   Psychedelic trials require unique operational approaches. Learn how to address patient safety, blinding, specialized assessments, and therapeutic setting considerations.

7. FDA Finalizes Psychedelic Drug Guidance: What Sponsors Need To Know 8/24/2026

   FDA's July 2026 final guidance on psychedelic drug clinical investigations sets expectations for sponsors developing psilocybin, LSD, and MDMA therapies. Learn what it means for your program.

8. Advancing IHC Assays From RUO To Clinical Trials And CDx 8/21/2026

   Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.

9. PMCF Requirements: Questions On Cost, Device Viability, And Where AI Fits In 8/20/2026

   PMCF costs are straining device budgets. Discover how AI-assisted review and real-world data from other regions can help you meet EU requirements more efficiently.

10. Operationalizing Global Oncology Trials: Fast-Track Development Timelines 8/20/2026

    Running oncology trials across multiple regions? Learn how coordinated planning, oversight, and expertise keep complex studies on track from start to registration.