11.22.22 -- Clinical Supply Planning For Studies With Unconventional Timelines

More drug sponsors are considering the advantages of conducting studies that deviate from standard timelines, including combined phases and adaptive designs. This Q&A discusses how these trials impact the supply chain, the role a CDMO can play in facilitating these trials, and the possible risks of such studies.

Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety, or cost. Review how clinical trial sponsors can determine the best strategy to meet these challenges.

A well-known, midsize, multinational pharmaceutical company needed a large supply of comparator drug to begin comparative clinical trials for a rare disease. The comparator drug presented two enormous hurdles: It was limited in supply and it was exceptionally expensive.

Successfully sourcing commercial products for comparative studies in an effective and efficient manner often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management.