Our research team is committed to the highest standards of performance in the conduct of clinical trials completed at our facility. We adhere stringently to all GCP and ICH guidelines, Federal regulations and the study protocol. Every study is assigned a primary, as well as secondary, research coordinator that is fully prepared to assume the duties of the primary coordinator on a temporary or permanent basis. We perform quality assurance audits on all trials which may include the examination of the investigator site file, source documents, case report forms, patient informed consent, inclusion/exclusion criteria, compliance with SOPs, monitoring reports and query resolution process. All results are discussed with appropriate team members.
We have a complete list of SOPs that govern the performance of all procedures of a clinical trial unless replaced by a specific study protocol or SOP. The topics covered are listed below.