Clinical Supply Regulation Resources

  1. Artificial Intelligence Regulation 12/13/2024

    To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines.

  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. Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide 1/12/2023

    Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.

  4. Clinical Manufacturing: What It Is And How It Works 2/27/2022

    Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

  5. Clinical Trial Logistics Provider Of The Year

    How can you utilize state-of-the-art GMP-compliant depot networks and logistics hubs to maintain product quality and safety standards for complex therapies?

  6. Decentralized Clinical Trials: A Win For Patients, Sponsors, & Investigators

    Learn how the integral role of Direct-to-Patient Services plays a part in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

  7. Navigating New EU Clinical Trials Regulation Requirements For Clinical Supplies

    Better understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategy that adhere to the new requirements.

  8. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

    Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

  9. Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain

    With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.

  10. 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.