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Clinical Research Auditing
IMARC Clinical Research Auditing Services

Auditing

Auditing

Your Site. Our Eyes.

With regulatory inspections on the rise, you need to be sure your site adheres to the most stringent requirements for compliance and patient protection. Our rigorous auditing process is designed to identify and address issues before the FDA finds them and prepare your team to answer questions with confidence.
Electronic Trial Master File Auditing

Comprehensive Auditing Services

Our auditing services are based on the FDA’s BIMO checklist and cover every aspect of your site, including protocol, IRB requirements, agreements, sponsor requirements and standard operating procedures. In addition to site GCP audits, we also provide sponsor/CRO audits and vendor qualification audits.
Study Logistics
Study Logistics
Study Implemations
Study Implementation
Ongoing Study
Ongoing Study Management
Study CloseOut
Study Closeouts
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Evaluate … Inspect … Prepare

There are unique risks to consider at every stage of a clinical trial. That’s why we use a multi-level approach that:
Evaluates your site, sponsor and vendors
Inspects your facilities, data and processes
Prepares your staff for inspections and interviews
Auditing
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