Medical Device Clinical Research Study Audits

See all medical device clinical consulting services.

Clinical research study audits are independent examinations of clinical trial data and activities. The intent of conducting a clinical trial audit is to ensure the capture, analysis and reporting of data in accordance with the study protocol, GCP, regulatory requirements and Standard Operating Procedures (SOPs).

Our qualified team of medical device clinical professionals in Europe, Japan, China, India or the US can perform the following auditing services to ensure compliance with all requirements outlined in the clinical study protocol:

SOPs audits
Master File audits
Database audits
Process audits
Investigator site audits
Clinical study report audits

We can work with you to determine what should be audited, how it will be audited, the frequency of those audits and how the clinical research study audit results will be presented. Often, the level of auditing is guided by the importance of the trial data to regulatory authorities, risk to the study subjects, and complexity of the clinical trial.