Newsletter | March 12, 2024

03.12.24 -- Novartis CAR-T Trials Highlight Complicated Clinical Supply Chain

FEATURED EDITORIAL

Novartis CAR-T Trials Highlight Complicated Clinical Supply Chain

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. 

INDUSTRY INSIGHTS

Developmental Testing Of IV Solutions

As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

Beyond Integration: Flexible Orchestration Of IRT And eCOA Solutions

Consider how integrated response technologies and electronic clinical outcomes assessments can improve configurability, study start-up, and flexible mid-study changes.

Optimizing Resupply To Reduce Risk Of Late Phase Delays

Early collaboration with a clinical supply manager can help proactively negotiate potential pitfalls. Learn efficient resupply practices and execute successful supply chain strategies.

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.

SOLUTIONS

Frozen Packaging Solutions

The Challenge Of Maintaining Sterility At Low-Temperature Storage