By Sandra Freeman
Outsourcing different aspects of the clinical study process is a growing trend; 64 percent of trials are currently outsourced. Of those that don’t currently, 54 percent plan to outsource in the future. Sponsors outsource to clinical research organizations (CROs) to control operational and infrastructure costs and allow them to concentrate on what they do best – drug development.
Although there are obvious benefits to outsourcing, it creates new challenges around quality, oversight, collaboration, and governance. With outsourcing, processes and systems are often duplicated or disparate. Sponsors, CROs, and sites use their own SOPs and processes, resulting in a duplicated effort and data entry.