Clinical Quality Assessment & Corrective Action Initiatives

Service Description

Clinical quality consulting services provided by Advarra Consulting (including Computer System Validation):

• Internal audits of Clinical Operations’ processes and documentation
• Audits of investigator sites and clinical trial master documentation and files
• Audits of Serious Adverse Event tracking and files
• Development of Clinical Trial Management System (CTMS) User Requirements Specifications
• Corrective action activities for enhancement and implementation of improved GCP standards to support regulatory compliance

Client

Mid-size device company (Clinical R & D), a subsidiary of a top global pharmaceutical company, involved in the conduct of global clinical trials (under IND Submissions in the US) using an approved, commercially available device in combination with an FDA-approved drug.

Clinical Situation

Complex clinical studies were being conducted in complex therapeutic areas without a clinical trial infrastructure that could maintain expected GCP quality standards. Written procedures were deficient in some areas and clinical program growth was so rapid that compliance with requirements was compromised. Serious deficiencies in the management of the global clinical trials, as well as SAE tracking and follow-up, were identified through internal audits and audits performed at clinical investigator sites. There was an immediate need for prioritized corrective action strategies.

Clinical Solution

Critical areas identified for improvement were prioritized by the client with Advarra guidance. Corrective action plans with Advarra evolved to a series of GCP improvement activities over a nine-month period. Consulting services shifted to corrective action and improvement activities which involved the mapping of fourteen (14) key Clinical Operations and Clinical Trial Management Process areas, encompassing all relevant and adjacent functional areas and disciplines. Services also included a detailed evaluation of written standards (SOP “Gap Analysis”) and enhancement and/or development of new standards (n=30), followed by training on each new standard for all relevant personnel.

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