Industry Insights

  1. How Can Sponsors Enable Research-Naïve Clinical Trial Sites 8/8/2025

    Technology is playing a critical role in enabling a shift to expanding site networks and alleviating site burden.

  2. Can Digital Endpoints Really Accelerate Clinical Trials? 8/8/2025

    Digital biomarkers are quickly and quietly becoming the digital revolution needed to make clinical trials quicker and more data rich. Discover how they are being used in clinical trials right now.

  3. Considerations For Subcutaneous, Intramuscular Formulation Development 8/7/2025

    Explore the changing landscape of parenteral delivery, considering the pros and cons of intravenous, subcutaneous, and intramuscular formulations, and how new technologies are reshaping drug delivery.

  4. Autoinjectors For Autoimmune Diseases: Benefits And Considerations 8/7/2025

    By improving convenience, ensuring precise dosing, and reducing dependency on healthcare facilities, autoinjectors enhance patient outcomes and quality of life.

  5. Considerations For Drug-Device Combination Products In Rare Diseases 8/7/2025

    The development process for these products is complex, requiring careful consideration of regulatory requirements, technical feasibility, clinical efficacy, and patient-centered design.

  6. Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch 8/7/2025

    Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

  7. Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making 8/7/2025

    Aligned with new FDA support for new approach methodologies (NAMs), Ronald Li, Ph.D, and Kevin Costa, Ph.D., share their story of creating Novoheart's mini heart organ model and discuss its current use in clinical trials.

  8. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  9. The Forgotten Stakeholder: Why Caregivers Are The Key To Clinical Trial Success 8/5/2025

    By designing protocols and support ecosystems that address caregiver concerns, sponsors not only improve trial outcomes but also foster trust and advocacy within family-dependent populations.

  10. Health Literacy Is The Hidden Enrollment Barrier: How PXO Closes The Comprehension Gap 8/5/2025

    In a landscape where health equity and patient-centered research are imperatives, PXO offers a scalable system to ensure every patient understands, engages, and stays.