Clinovative Research, Inc provides independent audits for sites, CROs, and pharmaceutical companies.  These audits will assist you with finding potential deficiencies or growth areas prior to a regulatory agency audit or prior to conducting business with a new business partner or site.  Our confidential report will contain a review of the organization’s SOPs, applicable files, staff training, and the overall facility.  Audits conducted prior to the start of clinical trials can often help set the expectations for each part of the clinical trial team and will strengthen the relationship between the site, CRO, and sponsor.  Independent review of your own organization will allow you to strengthen areas of concern or implement new policies before any issues arise.      

Audit Preparation

Our team of experienced Project Managers and Clinical Research Associates has assisted numerous sites and pharmaceutical companies with FDA and IRB audit preparation.  This includes:

• A presentation about recent audit findings, audit trends, and purposes of audits
• A review of all applicable regulations that govern your organization
• Review of the management structure or delegation log for the study
• Preparing for the interview with the inspector
• Reviewing what to provide to the inspector and acceptable formats for each document
• Review of applicable study documentation, including regulatory binders, trial master files, etc to ensure completeness of the files prior to the inspector’s arrival
• Review of your physical facility (to ensure patient confidentiality, investigational product compliance, calibration logs, etc)
• Review of your SOPs, including policies governing FDA’s hot issues (such as ICF and HIPAA for sites and data storage for sponsors).