GCT QA Department will plan, schedule, and conduct a series of investigative site audits in Bulgaria and Italy for a long-term partner.
The purpose of the audits is to evaluate the systems, processes, capabilities, facilities, and personnel available to determine the ability of the sites to adequately conduct, coordinate and monitor the specific study in compliance with GCP, applicable SOPs, and all applicable regulations and guidelines. Every trial requires the development of an audit plan to fulfill Sponsor obligations under ICH 5.1.1, and to provide verification of data integrity. GCT QA team routinely performs internal audits (offices, facilities, projects, departments), as well as provides services externally.
As a global CRO with more than 20 years of experience supporting Sponsors and life-changing therapies, we are grateful to our clients for trusting our services and coming back to us repeatedly.