03.09.23 -- Efficient Clinical Supply Management And Forecasting

Discover how to drive excellence within the forecasting process, how to utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines, and how to identify potential supply-related issues before they negatively impact your study.

The European Union (EU) Clinical Trials Regulation No. 536/201 (CTR) is expected to impact nearly every aspect of clinical research in the EU. This article examines CTR labeling changes and discusses their potential to disrupt traditional clinical supply strategy should sponsors misunderstand or fail to adhere to the new requirements.

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 was exceptionally expensive.