A Proactive Approach to Clinical Trial Material Preparation: The Manufacturing,Packaging,and Labeling Protocol

The preparation of clinical trial materials is a complex process. Even for simple clinical studies, numerous activities must be coordinated to ensure that the project proceeds efficiently. The process becomes even more challenging when contract facilities are used for some or all of the clinical trial material preparation. The successful completion of complex projects such as clinical trial material preparation is directly related to how well the project is defined and to how well that definition is communicated to the people responsible for performing project tasks. One method to facilitate the process is to proactively define and document the clinical supply project and the responsibilities of the project team members. One such document, a manufacturing, packaging, and labeling (MPL) protocol, can actually expedite entry into the clinic through its provisions requiring proactive planning, project team interaction, and detailed descriptions of project requirements.