Service Description

Almac is contracted to provide clinical supplies distribution to our multi-national Phase 3 clinical trial in the respiratory anti-infective area. They receive the drug supply from the contract manufacturer, label the vials in the appropriate language, package the vials in the box, provide appropriate temperature control and monitoring, ship the supplies to the country depot and ultimately ship the correct supplies to the randomized patient.

What Went Well

The clinical trial is in the early stages so most of the issues that have arisen are related to the quotation of services and contractual process. Almac provides quotations and proposals in great detail so you can see the amount of each activity or product that they are providing. Their contracts group is responsive.

What Could Be Improved

The clinical trial is in the early stages so most of the issues that have arisen are related to the quotation of services and contractual process. Almac was not good about asking the correct questions to understand the statement of work and develop the quotation correctly. Therefore, we had a cost growth from the original quotation to the current contract of over 2.5 times. The quotation format that they use makes it difficult for a reviewer to understand the "big picture" and leaves out significant costs (such as the cost to ship the clinical supplies to the subject).

Lessons Learned from the Experience

The lesson learned is that it is necessary to have someone intimately familiar with the clinical supplies distribution process read and review the proposal to ensure that the correct statement of work is included. I did not find that Almac made the proposal process easy for a sponsor to understand.