Clinical Supply Regulation Resources

  1. 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.

  2. Clinical Research Is A Delicate Ecosystem 4/18/2024

    Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.

  3. Building Better Resilience Into Your Clinical Supply Strategy 5/27/2026

    Reliable clinical supply requires proper vendor selection, cross-functional communication, and safety nets built to accommodate an ever-changing geopolitical and global pharmaceutical landscape. To avoid supply disruptions for clinical drugs, sponsors must give clinical supply its proper weight in initial protocol development and trial design.

  4. 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.

  5. Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials 5/12/2023

    Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

  6. A Smart Solution To Clinical Supply Management 10/28/2022

    Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.

  7. 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.

  8. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

  9. Improving Clinical Trial Label Translation Through Centralized Reuse And Control 8/10/2026

    Eliminate workflow inefficiencies and regulatory risk in global trials with a centralized translation framework and validated phrase library for consistent, cost-effective execution.

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

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