Regulatory Insights

  1. Harness An Adept IRB's Expertise To Streamline Study Design 10/2/2026

    An Institutional Review Board protects human research participants by evaluating study ethics, consent, and risks, while providing sponsors with ongoing guidance on complex trial protocols.

  2. Scaling Pharmacovigilance: From Clinical Development to Commercialization 10/1/2026

    Commercial growth brings new PV challenges. Gain practical insights on operating models, technology, governance, and leadership for long-term success.

  3. The Future Of Clinical Trials: AI, Real-Time Data, And FDA Innovation 9/30/2026

    How does building trial protocols into health records lets key safety and efficacy signals reach sponsors and regulators in days, cutting manual data entry and speeding decisions.

  4. The Future Of Clinical Trials: 7 Trends Redefining FSP Models By 2030 9/29/2026

    Learn why factors like decentralized trials and tighter global rules are pushing sponsors to favor fewer, deeply integrated, tech-driven partners over traditional staffing models for clinical outsourcing.

  5. ASCO To EHA 2026: From Incremental Gains To Early Impact: What Biotechs Must Do Next 9/28/2026

    Oncology is moving to earlier treatment. Learn how ASCO and EHA 2026 results can help you design faster, earlier-line trials that stay relevant as standards of care change and access gaps persist.

  6. Meeting The Complexities Of Modern ADC Development 9/28/2026

    A strong molecule is no longer enough. Learn how trial strategy and operational readiness can help your cancer therapy reach patients faster.

  7. NIH To Extend Plain Language Results Requirement To Funded Studies 9/24/2026

    New draft policy may require plain-language result summaries for clinical research participants. See what's in scope and how to prepare.

  8. 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.

  9. The Evidence Gap In Hematology: From Trial Endpoints To Patient Outcomes 9/16/2026

    Hematology trials face shrinking patient pools and fierce competition. Discover how real-world data and evidence can sharpen feasibility, site selection, and regulatory strategy.

  10. A New Chapter for Orexin Therapies: What's Changing in Drug Development 9/16/2026

    Join Beatrice Setnik, PhD and Denise Milova, PhD, for a conversation on orexin rescheduling and the evolving regulatory landscape.