Industry Insights

  1. 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.

  2. Project Optimus Explained: 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.

  3. Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research 7/2/2025

    CEO Marc Deschamps shares how ischemic stroke treatment has overshadowed that of intracerebral hemorrhage, negatively impacting recruitment for ICH clinical trials. To turn the tide, he advocates for accurate diagnoses, more specialized care, and less restrictive enrollment criteria.

  4. 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.

  5. 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.

  6. 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.

  7. Insights From Facilitating Over A Billion Dollars In Vendor Contracts 7/1/2025

    By transforming vendor selection from a manual task into a data-driven, strategic process, sponsors can build stronger, more effective clinical trial teams.

  8. 10 Roadblocks To Traditional Vendor Selection And How ClinAI Solves Them 7/1/2025

    Vendor selection in clinical trials is a pivotal process. Explore ten widespread inefficiencies in the current approach and how you can resolve them.

  9. Best Practices For Gene Therapy BLA/MAA Submissions 7/1/2025

    Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

  10. Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What 7/1/2025

    What do air traffic control, nuclear power plants, and aircraft carriers have in common? Patient recruitment expert Tatty Scott argues clinical researchers should look at these industries to inspire more precise trial execution.