Site Auditing
& Monitoring

It is guaranteed that you will be inspected by one or more governing bodies as you move through your Clinical Trial

From the inception of a clinical trial, it is critical to have evidence of full compliance to regulatory requirements in all stages of the testing and submission. Compliance Team provides thorough qualification services of vendors, including CROs and CMOs, Clinical Investigator Sites and testing laboratories, as well as in-process audits and monitoring services to ensure you have evidence of regulatory compliance, and can remediate deviations from protocol or procedures,  throughout all phases of the trial.

We also ensure that Sponsors adhere to all Data Protection and patient safety laws and standards through audits of the IRB, the Sponsor, and all computer systems and patient safety programs.

Our main goal is to provide proof of compliance throughout the Clinical Trial, and to deliver a CAPA plan for areas of the trial which require remediation. We perform detailed reviews on patient data, Clinical Study Reports, and Trial Master Files.

It is guaranteed that you will be inspected by one or more governing bodies as you move through your Clinical Trial. Our experts provide comprehensive Inspection Readiness Audits of your Clinical Investigator Sites as well as your operations site. Our standard practice for Inspection Readiness is to provide a full mock inspection, followed by staff training to ensure you are prepared to pass a regulatory inspection.

We will provide you with documented evidence of compliance to regulations for a successful submission.