Regulatory Insights

  1. GLP-1 Ocular Safety Monitoring At Point-Of-Need 9/8/2025

    Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION).

  2. Five Questions Biotechs Should Ask Before Selecting A Bioanalytical CRO 9/2/2025

    In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional; it is essential to survival and success.

  3. Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows 9/2/2025

    Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.

  4. Writing An IND Module 3 For Cell And Gene Therapy Products 9/1/2025

    This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

  5. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

    As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

  6. Gene Therapy Studies Rose While Financing Declined In Q2 2025 8/13/2025

    There were three new approvals across the therapeutic landscape in the second quarter of 2025, but despite those positive signs, overall dealmaking was flat for the quarter.

  7. Demanding More From AI Governance In Drug Safety 8/13/2025

    Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

  8. 5 Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

    Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

  9. Managing Risk And Regulation In Clinical Trial Technology 7/31/2025

    Now is the time to evaluate your current risk management framework. Take action today to strengthen your safeguards, tailor your risk assessments, and prioritize transparent patient engagement.

  10. AI Maturity In Clinical Development 7/30/2025

    The future of clinical research relies on operationalizing AI in a scalable, sustainable manner, ensuring that both technological and human factors are harmonized in this transformative journey.