What Inspection Readiness Means for Sponsors and CROs
In short, the point is that the trial sites work fully GCP-compliant. But how do you achieve that the study teams at the trial sites do this?
A GCP training every two years for all site staff is not sufficient. The principles of ICH-GCP must be understood and internalized by all participants – site staff and clinical monitors.
If the study teams only occasionally conduct clinical trials, they need support in defining and implementing GCP-compliant workflows. They need support in how to document study data in the patient files in a GCP-compliant manner.
With High Quality Monitoring we have developed a methodology with which all-time "Inspection Readiness" can be achieved. Our concept includes, among other things, a method to keep the contents of investigator site files and the trial master file at the sponsor site consistent from the start to the end of the study.
Thus biopharmaceutical and medical companies gain clinical data at the highest quality level and avoid the increased resources for preparing audits and inspections and the associated costs for the later implementation of Corrective and Preventive replica Actions CAPAs.
The current ICH-GCP Guideline E6 (R2) has already been taken into account in our methodology.