FDA Inspections Of Clinical Investigators: Are You Ready?Source: MasterControl
Published Jointly By MasterControl Inc. and Fujitsu Limited
Life science companies are developing cutting-edge medicines, medical devices, and therapies that entail increasingly complex clinical trials. As a result, regulators throughout the world have to step up their vigilance in overseeing clinical trials to ensure the safety of participants and the integrity of clinical research.
In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to strengthen its oversight of clinical investigators and clinical trials. In Europe, tougher regulations for medical devices are being proposed by the European Commission, including stricter rules for notified bodies that conduct inspections during clinical trials.
The increased focus on clinical trials means sponsors and CROs can expect more stringent (if not more frequent) inspections. If your company is sponsoring a clinical trial or if it’s a CRO conducting research on behalf of a sponsor, are you ready for an inspection?