Clinical Supply Regulatory Articles

1. When Drug Supply Has A Half-Life: Radiopharmaceutical Logistics 10/1/2026

   Radiopharmaceuticals turn time into a supply-chain constraint. Short half-lives, patient scheduling, scarce radionuclides and regulatory differences reshape trial logistics.

2. Segregation Of Duties: Drug Accountability Needs Three Separate Roles 9/28/2026

   When one person orders, receives, and reconciles investigational product, a critical control disappears. See how role separation can strengthen drug accountability.

3. Before The Excursion: The Governance Decisions That Should Already Be Made 9/24/2026

   Temperature excursions are inevitable. The real risk is the time lost deciding what to do. See how preplanned governance can turn long quarantines into routine events.

4. The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem 9/17/2026

   The wrong regulatory filing sequence can close faster pathways, delay importation, and consume shelf life. Here’s how regulatory strategy can reshape clinical supply.

5. CSM Feasibility Begins With Research Strategy And Study Design 9/15/2026

   Study design decisions can create costly clinical supply problems months later. Early CSM review can expose hidden requirements before they become delays, waste, and rework.

6. Clinical Supply Systems Need IT General Controls 9/14/2026

   Validating a clinical trial system does not prove it stays trustworthy. IT general controls can protect data, supply decisions and patient safety long after go-live.

7. Expanded Expertise, Deeper Insight: Clinical Supply Leader Welcomes Two New Advisors 9/4/2026

   Clinical Supply Leader expands its Editorial Advisory Board expertise with the addition of Éamonn McArdle (Allergy Therapeutics) and Juan Hernandez (Bensen Solutions).

8. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

   Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

9. Managing Customs, Import/Export Requirements, And Cross-Border Logistics Challenges 8/10/2026

   Customs delays can derail clinical trials in days. Learn practical strategies for import compliance, digital preclearance, and resilient cross-border logistics.

10. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.