Biopharmaceutical sponsors face common challenges across nearly all clinical trials, including minimizing risks, meeting inflexible deadlines, and maintaining control of each aspect of ongoing studies. Critically, the extent of this control depends on the sponsor’s outsourcing partner(s).
To ensure adequate command over its project, a sponsor must be confident its partners possess a comprehensive knowledge of their roles, as well as an awareness of current issues with any ongoing study and a plan to address those hindrances. Additionally, the sponsor must be kept well-informed of all thought processes and occurrences associated with its studies, empowering its leadership to make vital decisions quickly, with that conviction its input is validated and a vital part of any solution. Finally, the sponsor should expect swift responses to any questions or concerns.
Unfortunately, biopharma companies — particularly smaller or emerging organizations — often are unable to draw maximum value from their clinical research outsourcing (CRO) partners. This occurs for any number of reasons, four of which are covered in this e-book.