Client Business Situation
Client was a large physician practice group with a substantial clinical study practice. Due to the nature of the studies conducted and association with significant pharmaceutical company clinical trials, FDA conducted an inspection of the practice location and conduct of individual clinical studies. This was the first experience the practice had with an FDA inspection, and despite best efforts to comply with the requirements before being visited by the FDA, the FDA issued a multi-item FDA-483, highlighting deficiencies with multiple aspects of their quality systems.
Client Business Pain
Without assistance, the client would have been in jeopardy of significant FDA enforcement action due to the issues found during the FDA inspection of their clinical site. The client’s clinical practice was extremely successful and poised for growth and such an enforcement action would substantially limit their chance for further study participation.
Solutions Provided / Services Delivered
Compliance Architects® performed a thorough analysis of the issues identified within the FDA-483 and assessed additional compliance and system gaps related to, and going beyond, the identified observations. Operations were further assessed against FDA’s Good Clinical Practices (GCP) requirements and expectations. Immediately thereafter, a response to the 483 was drafted under Compliance Architects® direction. A remediation plan tied to the response was prepared with specific, targeted deliverables and milestones. Tactical development of individual SOPs, forms, and trial execution records was conducted by the lead onsite consultant. Training of all staff, up to and including the physician practice leads was conducted to assure full understanding of the new systems. Mentoring of staff through initial experiences with the new systems and practices was essential for long-term success.
Benefits Realized
The FDA expressed no negative comments on the FDA-483 response and the client has not received any further enforcement action by the FDA. In addition, the practice has a much more robust quality system in place for the governance of the clinical studies, and all parties know their roles and expectations under the regulations. This enhanced capability has allowed the client to continue with their clinical practice and expand operations beyond the studies that it had already been performing.