Best of March: Top 5 Insights In Clinical Supply Chain & Logistics

#1 - Do ClinOps Professionals Understand The CAR-T Supply Chain?

In her interview with chief editor Dan Schell, 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.

#2 - IMP Labeling: EU CTR Transition Considerations

Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

#3 - The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials

Understanding the differences of expanded access programs and investigator sponsored trials from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

#4 - Factors In Developing Injectable Drug Placebo Formulations For Pharmaceutical Clinical Trials

Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

#5 - What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production

Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.