Industry Insights

  1. Is The Industry Ready To Trust LLMs With Chart Review? 5/27/2026

    See how LLM-powered extraction transforms unstructured medical records into compliant, audit-ready clinical data with machine-scale speed, human oversight, and regulatory-grade accuracy.

  2. AI, Virtual Participants, and the Evolving FDA Regulatory Landscape 5/27/2026

    Understanding emerging requirements around transparency, risk, and governance is essential for responsibly advancing AI-driven innovation in regulated environments.

  3. The ctDNA Clinical Trial Advantage 5/27/2026

    See how CROs are helping shape the future of ctDNA research—translating emerging data, regulatory insights, and biomarker innovation into faster, smarter oncology development.

  4. Mergers And Acquisitions: How Institutional Knowledge Protecting Value 5/27/2026

    M&A transitions can either preserve momentum or create costly setbacks. Learn how protecting institutional knowledge helps sponsors reduce risk, maintain continuity, and accelerate development.

  5. Simultaneous Submissions And Managing Multiple Regulatory Pathways 5/27/2026

    Global regulators are increasingly aligned, creating new opportunities for sponsors to pursue near-simultaneous submissions across major markets

  6. Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation 5/27/2026

    Should informed consent really start with clinical trials ads? And if not, why do IRBs need to be involved in their approval? Paul Ivisin unravels the tangled web of IRBs, regulators, and clinical trial advertisements.

  7. How ReTrans Supports Smarter Literature Surveillance In Pharmacovigilance 5/26/2026
  8. From Submission Document To Lifecycle Safety Tool: Why RMPs Need Ongoing Attention 5/26/2026

    Actively maintained risk management plans improve safety oversight, data alignment, and regulatory confidence well beyond initial approval milestones.

  9. FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors 5/26/2026

    Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.

  10. Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials 5/26/2026

    BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.