Insights on Clinical Trials

  1. Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry 7/8/2025

    Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

  2. CMC Strategies For Cell And Gene Therapy Development 7/2/2025

    The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

  3. Project Optimus: Shifting Away From Maximum Tolerated Dose 7/2/2025

    Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

  4. How We Used Intelligent Automation to Transform Vendor Selection 7/2/2025

    Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.

  5. Reframing Clinical Vendor Selection 7/2/2025

    Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.

  6. Commercializing Your First Cell Or Gene Therapy (CGT): Developing Your Market Access Strategy 7/2/2025

    Effectively commercializing cell and gene therapies requires a strong market access strategy. Learn key steps for ensuring your therapy reaches patients at the right time and place.

  7. Pushing The Boundaries In Cell Therapy: CAR-T Updates From EHA 2025 7/2/2025

    The 30th European Hematology Association (EHA) Congress in Milan highlighted a more mature CAR-T therapy landscape, where rapid manufacturing, durable responses, and improved safety profiles are converging.

  8. The Ten Commandments Of Vendor Selection 7/1/2025

    Selecting the right vendors sets the foundation for efficient operations and reliable outcomes, and these ten essential principles can guide sponsors in making informed vendor choices.

  9. The Founder Behind The Platform 7/1/2025

    Learn about the founding and mission of ClinAI, a groundbreaking platform that leverages automation and analytics to enhance vendor selection and management.

  10. Productivity Hacks For An Effective RFP / Clinical Trial Vendor Selection 7/1/2025

    Starting a new clinical study requires careful vendor selection and these practical, actionable steps to enhance your selection process and ensure long-term partnership alignment.