Newsletter | May 26, 2020

05.26.20 -- Considerations For Clinical Supply Efficiency

Managing Risks To Time-Critical Product Imports At Clinical Supply Depots

Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the U.S., an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Israel.

Questions You Need To Ask About Clinical Supply

Planning on using a CRO to support your next clinical study? Here are the top nine questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.

Innovative Clinical Supply Solutions: Cold Chain

A biopharmaceutical company known for the development of novel therapeutic drugs had a critical requirement to package a biohazardous frozen drug product. However, the client possessed no stability data at the project onset, which was an essential parameter in determining the need to keep the product frozen. Learn how the product was successfully packaged in sufficient quantity and on time for the Phase I trial.