Clinical Supply Logistic Articles

1. Adapting Clinical Supply Strategies Through The Phases 5/17/2024

   Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.

2. Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances 5/10/2024

   Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.

3. 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.

4. FDA Publishes Final Guidance On Reporting Listed Drug Amounts 4/10/2024

   Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.

5. What Really Happens When A Cell Therapy Supply Chain Fails? 4/5/2024

   A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.

6. Best Practices For Clinical Supply Chain Management In Rare Disease Trials 3/27/2024

   A supply chain pro discusses three of the greatest challenges in clinical trial supply management for rare diseases and strategies to overcome them.

7. How To Prevent And Manage Temperature Excursions In Clinical Trials 3/20/2024

   Temperature excursions can have devastating effects on drug product for clinical trials. Here are some ways to avoid them and protect the cold chain.

8. Supplying Complex, Controversial, And Intercontinental Clinical Trials 3/13/2024

   Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.

9. Do ClinOps Professionals Understand The CAR-T Supply Chain? 3/4/2024

   Lee Clough RN, HP, of Novartis talks about the importance of understanding the nuances associated with collecting and shipping autologous material (i.e., CAR-Ts) for clinical trials. 

10. The Impact Of Protocol Design On An IRT System 1/31/2024

    DTP and home treatment studies can get expensive — and be a hassle to patients — if the IRT element isn’t well planned for during trial design. In their SCOPE Summit presentation, Irina Grishina and Kelsey Kern of CSL Behring plan to share their personal anecdotes and lessons learned from both types of trials as they pertain to IRT.