Clinical Supply Regulation Resources

  1. Benefits Of Electronic Labels: Investigational Medicinal Products 12/2/2022

    When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.

  2. Five Key Trends In CMC 3/18/2025

    CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

  3. Overcome Vaccine Development Complexities With The Right Supply Chain Partner 7/5/2022

    Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.

  4. Master Protocol Studies: Technology Considerations For The 'Never Ending' Clinical Trial 1/6/2022

    Since the FDA is now encouraging creativity in trial designs, it is important for all stakeholders to adapt processes to follow the science and ultimately bring medicines to patients, faster. This white paper addresses the complexities that come with these trial designs, and how randomization and trial supply management (RTSM) solutions are critical to run flexible, robust, and quality-driven trials.

  5. IQVIA Labeling Compliance Solutions 5/16/2023

    Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.

  6. Choosing RTSM? Evaluate The Team Running It, Not Just The Software 2/25/2026

    High-performing RTSM requires more than just code. Discover why team continuity and clinical expertise are the most overlooked factors in reducing trial risk and ensuring regulatory compliance.

  7. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

  8. Advantages Of Robotic Aseptic Processing 10/6/2023

    Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.

  9. Quality Assured: Bringing Life-Changing Therapies To Patients 1/12/2023

    Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.

  10. European Clinical Supply Planning – Balancing Cost, Flexibility, And Time 3/13/2026

    By evaluating the key parameters of a study, sponsors can identify the most effective location for packaging and distributing clinical trial supplies.