Newsletter | March 19, 2024

03.19.24 -- Unique Challenges Of Clinical Supply For EAPs And ISTs

FEATURED EDITORIAL

Why EAPs And ISTs Each Have Unique Clinical Supply Considerations

Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

INDUSTRY INSIGHTS

Developing Injectable Drug Placebo Formulations For 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.

Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials

Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

State Of Clinical Inventory Management At Sites

Did you know that 75% of clinical research sites keep track of their inventory using spreadsheets and paper? Understand the challenges sites face when handling inventory and how to overcome them.

Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

This study assesses the integrity of a chosen vial-stopper-seal combo when frozen at -80°C, examining material, processing, and sealing conditions for stability.

SOLUTIONS

Managing And Moving Your Advanced Therapeutic Product

Re-Imagining IRT For Modern Clinical Development