Clinical Supply Packaging Articles

1. Where Clinical Supply Chain Meets Humanity: Why It's Never "Just A Box" 1/27/2026

   Clinical supply chain decisions move more than inventory. They influence dignity, safety, and patient outcomes every day.

2. Digital Tools Are Failing Patients: 3 Ways Clinical Supply Can Protect Data Integrity 1/16/2026

   Getting drugs and devices to the doorstep is only half the battle. When digital connections fail, trials fail. Why the digital last mile needs clinical supply ownership, human-centered design, and tech support with a bedside manner.

3. Clinical Supply's Role In Driving Success In Decentralized Trials 12/11/2025

   Decentralized trials are a challenge for supply chain professionals. Explore how logistics, labeling, and home delivery make or break trial outcomes.

4. The New Clinical Packaging Paradigm: Differentiation And Decentralization 7/8/2025

   The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?

5. Good Distribution Practice Is Evolving — Here's How 5/15/2025

   Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

6. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

7. Should You Be Using Unique Container Identification? 8/22/2024

   Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

8. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

   The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

9. Cryo-Shippers: Challenges, Controls, And Logistics 1/3/2024

   Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.

10. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.