Process Assessments Lead to a Successful Mock FDA Inspection
Advarra Consulting conducted a series of individual, yet synchronized, Process Assessments of:
- Clinical Operations, Clinical Trial Management, and Quality Management Practices
- Pharmacovigilance and Drug Safety Surveillance;
Post implementation of Advarra’s process assessment recommendations, Advarra consultants planned and conducted a Mock FDA Inspection, which incorporated several of the company’s pivotal studies. Indirectly related, Advarra consultants supported the implementation of a Clinical Trials Management System (CTMS) by assisting the client with Functional Specification Development, Software Vendor Selection, and Project Implementation Management.
Advarra consultants provided value-added services to this small Bio-Pharmaceutical company involved in the conduct of US-based clinical trials to support the filing of their first New Drug Application to the US Food and Drug Administration.
With several large clinical study programs being conducted simultaneously, client and client CRO partner’s infrastructure and resources were being maximized. As this was the client’s lead product candidate, management required assurances that study conduct was adequate and in compliance with regulatory requirements, risks were known and minimal, and process efficiency was optimal.
Advarra consultants assessed processes in all identified critical areas, determined compliance with existing benchmarks, and provided useable guidances for improved compliance and efficiency. Assessment summaries were provided to the client in the form of presentations and reports for future consideration. Actionable items were identified and managed to completion with the assistance of Advarra personnel. This resulted in the client revising several procedures within the overall SOP portfolio, developing some new procedures as a result of the Gap Analysis, and implementing specific training initiatives; namely, an interactive training delivery system.