By Stephanie Gaulding, managing director, Pharmatech Associates—a USP company
Building strong relationships with partners, namely CDMOs and CROs, relies on a solid outsourcing framework. Part of this framework centers on ensuring that drug sponsors provide the necessary oversight of their outsourcing partners, across the product development cycle. The ideal operating model for these engagements is one where the drug sponsor calibrates its oversight to the specific nuances of its CDMO and CRO partners according to the details of each relationship.
Defining criteria ahead of time minimizes surprises, allows for fluid communication between the entities, and results in optimum performance. The aim of this planning process is quick and accurate response. Review three key areas that should be built into your outsourcing framework and agreements.