Industry Insights

  1. Technology Fragmentation Is One Of The Biggest Hidden Risks In Clinical Trials 4/6/2026

    Reclaim your research day by reducing manual data entry. Learn how connecting operational and financial workflows eases administrative burdens and supports site sustainability.

  2. The FDA's Final BIMO "Processes And Practices" Guidance 4/6/2026

    Gain a clear roadmap for investigators, sponsors, and IRBs. This shift toward transparency replaces regulatory guesswork with predictable standards for every partner in the research ecosystem.

  3. What Does The FDA's 2025 Safety Reporting Guidance Mean For You? 4/6/2026

    New FDA guidance aligns IND safety reports with unanticipated problems, shifting the focus from administrative definitions to proactive participant protection and trial integrity.

  4. Why Clinical And Commercial Development Must Be Integrated Fully And Early For FDA And Reimbursement Success 4/6/2026

    With clear alignment among clinical development, regulatory, and commercial development processes, sponsor companies can better prepare for FDA approval and successful Medicare reimbursement.

  5. With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout 4/3/2026

    Crystallis President and CEO James Mackay shares insights from the company’s clinical decision-making for dotinurad, including the inclusion of an open label extension. 

  6. RWD Helps Researchers Include More Patients In Lymphoma Research 4/2/2026

    Andrew Evens, DO, MBA, explores how outcomes research and collaboration across academic networks, registries, and industry partners are advancing more inclusive, data-informed approaches to lymphoma research.

  7. Paper COAs In 2026? It's Not "Cheaper," It's Riskier 4/1/2026

    Paper-based assessments add operational and regulatory risk — from poor data quality to delayed insights — quietly threatening timelines, compliance, and trial confidence.

  8. Could Study Rehearsals Create A New Standard For Site Readiness? 4/1/2026

    Giving sites the chance to rehearse a trial ahead of their initial study visits could lead to improved readiness, protocol adherence, and participant experience.

  9. Which FIH Decisions Are Hardest To Reverse Later? 3/31/2026

    Early oncology trial decisions can lock in risk, shape regulatory confidence, and limit flexibility. Knowing which choices are hardest to reverse protects optionality and credibility.

  10. The Much-Feared FDA Form 483, Part 2 3/31/2026

    Dr. Robert Califf argues that FDA Form 483, while useful for identifying issues in clinical research, is often applied punitively, causing reputational harm and unnecessary complexity. He advocates for a contextual, quality‑focused approach supported by AI and modernized guidelines to improve evidence generation efficiently.