Regulatory Insights

  1. The Flexibility Of Reconsent In Clinical Trials 5/9/2025

    Explore the common misconceptions surrounding reconsent, as well as the reality of its ability to be a flexible, ethics-driven communication practice grounded in respect for participant autonomy.

  2. The Future Of AI In Clinical Research, Delivered Today 5/8/2025

    The FDA's new guidance outlines a future where AI models support regulatory submissions, taking a pivotal step toward modernizing regulatory science.

  3. Transforming First-In-Human Oncology Trials: A Strategic Guide 5/6/2025

    Drawing from extensive experience in early-phase oncology, this guide offers a strategic framework for executing first-in-human (FIH) oncology trials with a patient-centric and risk-based approach.

  4. Assessing Diversity In Early-Phase Clinical Trials In A Rapidly Changing Regulatory Environment 5/5/2025

    Learn more about structuring early-phase trials to address population variation and the contributing factors to safe drug administration, both of which are essential to a drug development plan.

  5. Precision Medicine In Pediatrics: Biomarkers and Assay Development 5/2/2025

    Discover the rise in FDA-approved pediatric therapies and the role of precision medicine in tailoring treatments to genetic profiles, as well as how biomarkers and assays can enhance pediatric care.

  6. Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy 5/2/2025

    In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

  7. Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology 5/2/2025

    Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.

  8. The Crucial Role Of Audit Trail Data In Clinical Research 4/23/2025

    How can modern clinical trial systems leverage AI-driven audit trail reviews to ensure data authenticity, regulatory alignment, and strategic advantage?

  9. Blueprint For Efficient Clinical Trial Disclosure 4/21/2025

    Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.

  10. How The FDA Is Phasing Out Animal Testing Requirement 4/21/2025

    The FDA is embarking on a transformative initiative to phase out animal testing requirements.