By Dr. Paul Ingram, Catalent Pharma Solutions
An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. The complex nature of some clinical trials can create challenges which can place considerable stress on the supply chain. The difficulty in ensuring the continuity of supply increases as variables are introduced into the mix. These variables can include blinded studies, those with multiple arms or dynamic designs such as adaptive studies, fluctuations in patient recruitment, insufficient or interrupted supply of the IMP or comparator drugs, and more.