Insights On Trial Design

  1. Strategic CMC Considerations For Pre-IND Meetings: Setting The Stage For A Successful TPP 9/1/2025

    In biotechnology, the Pre-Investigational New Drug (Pre-IND) stage is a critical juncture. Explore the pivotal role of Chemistry, Manufacturing, and Controls (CMC) in navigating this phase.

  2. Shifting Policies Can Spark Progress In Clinical Trial Diversity 2/13/2025

    Learn how shifting policies create opportunities for the private sector to prioritize innovation in clinical trials for better healthcare.

  3.  Life Sciences Meetings Need More Than Logistics 8/6/2026

    Life sciences meetings often extend beyond investigators’ meetings. Strong planning helps teams support clinical, commercial, governance, and internal programs without adding pressure to the host team.

  4. Operationalizing Immuno-Oncology Studies 5/29/2026

    Managing CRS and immune risks demands early detection, rapid response, and skilled teams. Strong infrastructure and clear protocols enable safer immunotherapy trials beyond academic centers.

  5. Protocol Design Choices That Trigger IRB And Regulatory Requirements 8/20/2026

    Learn how protocol choices like AI, adaptive designs, and decentralized methods impact IRB review, participant protections, consent, and key regulatory requirements in clinical research.

  6. Can Your RTSM Software Vendor Handle Your Clinical Trial's Timeline Slip? 3/25/2026

    This clip examines why shifting study timelines expose weaknesses in rigid RTSM systems and highlights how flexible technology helps trials stay on track when plans inevitably change.

  7. Building Recruitment Into Early-Phase Trial Design 7/30/2026

    Successful recruitment starts with smart study design. Early recruitment insight improves feasibility, supports realistic timelines, and reduces enrollment risk.

  8. Podcast―Nonclinical Considerations When Developing Ophthalmic Drugs 2/20/2025

    Globally recognized consultants discuss how they are addressing the most pressing drug development topics in the ocular field.

  9. Pioneering Clinical Research For Native American Communities In South Dakota 1/31/2025

    Lynn Bartholow is transforming clinical research for Native American populations. Explore her journey into clinical research and efforts to build trust and foster participation and community engagement.

  10. Decentralized Trials: The Value Of Direct-To-Patient, Pharmacy-Led Solutions 5/8/2026

    Pharmacy-led DTP models cut site burden, improve inventory control, and expand trial access. Learn how to optimize your decentralized trial supply chain for compliance and patient outcomes.