Insights on Clinical Trials

  1. How To Establish Strategic Readiness For First-In-Human Trials 4/29/2026

    Most teams realize too late that sequential planning creates delays. FIH readiness depends on aligning IND and clinical strategy early; otherwise, programs risk setbacks that stall execution and timelines.

  2. Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D 4/27/2026

    Sana Biotechnology and Mayo Clinic are partnering to standardize delivery of a one-time hypoimmune cell therapy, aiming to scale access and redefine care for type 1 diabetes.

  3. From Bench To Breakthrough: How Custom Kitting Fuels Precision Trials 4/27/2026

    Reduce trial variability and ensure protocol compliance with standardized custom kitting that transforms complex sample collection into a streamlined, strategic advantage for clinical success.

  4. When CGT Supply Chains Break Down: 5 Operational Gaps That Put Patient Outcomes At Risk 4/22/2026

    Examine five of the most consequential gaps in CGT supply chain performance and learn what high-functioning teams do differently to protect patient outcomes before a failure occurs.

  5. Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation 4/15/2026

    Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.

  6. Target Selection Drives The Future Of CAR T Therapy In Solid Tumors 4/13/2026

    Target selection is the defining challenge in CAR T therapy for solid tumors, shaping safety, efficacy, and the field’s path forward.

  7. How Australia's Top CRO Speeds Biotech to Global Markets 4/8/2026

    The next era of clinical trials will be defined by global expansion across the Asia-Pacific region, rapid and cost-effective pathways to regulatory approval, and reliable, patient-centric leadership.

  8. Real-World Evidence Revisited 4/6/2026

    Explore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Learn the new standards for data reliability and hybrid study design.

  9. General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update Means 4/6/2026

    The FDA’s 2026 guidance has put an end to "wellness by disclaimer." Learn how new standards for wearables and apps impact study design, participant safety, and the evolving ethical role of the IRB.

  10. Clinical Decision Support Software: Clear Expectations For Research Oversight 4/6/2026

    The FDA’s 2026 CDS guidance signals a shift to settled policy. IRBs must now demand greater transparency regarding automation bias and clinician independence to accurately assess study risk.