Regulatory Insights

  1. The 2027 RWE Playbook: Regulation, AI & Data Reshape Evidence 9/17/2026

    New guidance is raising the bar for real-world evidence. Get a practical framework for auditing your data sources and closing traceability gaps before 2027.

  2. CTIS Results In The Spotlight 9/15/2026

    A new study finds fewer than half of EU Clinical Trial Information System (CTIS) trials met results reporting requirements. The EMA is now watching more closely. Here’s what sponsors need to know.

  3. Executing A Complex Global Breast Cancer Trial In A Rapidly Evolving Treatment Landscape 9/14/2026

    See how rapid site activation, strong oncology site relationships, and adaptive protocol management kept a complex global cancer trial on track amid evolving standards of care.

  4. Mobile Ophthalmic Assessment Options For Decentralized Clinical Trials 9/10/2026

    Eye exams need calibrated equipment and trained staff. These three mobile delivery models bring that capability directly to your trial participants.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.