Industry Insights

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design 3/31/2026

    Opus Genetics CEO George Magrath, MD, shares the team’s experience with an adaptive Phase 1/2 trial design for an ocular gene therapy.

  7. Building A Future-Proof, GxP-Compliant IT Infrastructure 3/31/2026

    Learn how a structured IT evaluation framework can help companies model total compliance costs, request vendor qualification evidence, and embed governance requirements into infrastructure selection.

  8. The Much-Feared FDA Form 483 3/31/2026

    Dr. Robert Califf explains that FDA Form 483 is often misunderstood as a final judgment, when it is actually an initial notice of potential issues found during inspections. He argues the form should be seen as a tool for quality improvement, not a proxy for overall performance, and he calls for more efficient processes to reduce unnecessary anxiety and delays.

  9. Medical Device Clinical Trials: Key Considerations For Sponsors And CROs 3/30/2026

    Medical device trials must align risk class, regulations, and study design. Strong oversight, data, and proactive safety planning support reliable evidence and market approval.

  10. A Guide To Medical Coding In Clinical Trials 3/30/2026

    Medical coding transforms free-text clinical data into standardized terminology, enabling consistent analysis, safety monitoring, and regulatory review. Clear guidelines and quality control help reduce variability and protect data integrity across the entire clinical trial lifecycle.