Insights on Clinical Trials

  1. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

  2. Dispelling Common Clinical Trial Oversight Myths 6/17/2025

    Many clinical trial oversight problems can be avoided or mitigated by sponsor understanding root causes and being a proactive collaborator with its partners.

  3. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

    The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

  4. Precision Project Management In Action 6/12/2025

    Discover how a tailored, risk-based project management approach was used to overcome the challenges of a complex Phase I/IIa FIH multi-country study of an advanced therapy medicinal product (ATMP).

  5. Huntington's Disease Clinical Trials: Innovation, Challenges, And The Road Ahead 6/11/2025

    The Huntington’s disease (HD) landscape is undergoing rapid transformation driven by breakthroughs in gene-targeted therapies, small-molecule modulators, regenerative medicine, and digital innovation.

  6. Leveraging AI To Transform Neurodegenerative Drug Development 6/11/2025

    Explore how AI is redefining the development pipeline for neurodegenerative diseases (NDDs), offering a path forward in the quest for effective, disease-modifying treatments.

  7. How Strategic Resourcing Accelerates Biotech's Path From Preclinical To FIH 6/11/2025

    Explore how strategic resourcing, particularly through FSP models, empowers biotech sponsors to overcome common hurdles transitioning when from preclinical research to first-in-human (FIH) trials.

  8. ThinkLive Cell and Gene Therapy Summit 2025 Summary 6/11/2025

    From patient support to intricate logistics, ThinkLive CGT Summit 2025 leaders tackled the essential commercial strategies needed to deliver these innovative therapies to patients globally.

  9. Effective Recruitment Capabilities And Outstanding Customer Service 6/10/2025

    Hear from many customers who commend OpenClinica's effective recruitment capabilities, outstanding customer service, and adept problem resolution.

  10. Optimizing Clinical Data: Reducing Redundancy For Efficiency 6/6/2025

    Enabling sites to focus solely on critical data facilitates faster data entry, reduces queries, and fosters better relationships between sponsors, CROs, and sites.