Clinical Supply Regulation Resources

  1. 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.

  2. The Changing Landscape Of Oncology Drug Development 5/17/2022

    Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.

  3. Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

    Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.

  4. AI-Driven Signal Management: The Future Of Drug Safety 12/19/2025

    By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.

  5. Writing Effective Clinical Regulatory Documents For Therapy Trials 7/11/2025

    Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

  6. The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective 3/29/2021

    Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.

  7. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

  8. 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.

  9. Leveraging The Bolar Exemption To Accelerate Market Access 3/17/2023

    Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

  10. Avoiding The Risk Of A Non-Transparent Clinical Supply Solution 8/27/2021

    With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.