Clinical Supply Management
Summary: A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment. This necessitated patients to continue with drug assignment visits through at least the following 11 months. With the challenge of assuring continuous supply of drug treatment available to meet study needs, the client called upon Catalent Clinical Supplies Management (CSM) to support the study during this final phase to ensure that no patient would be without ongoing treatment.