GCP Auditing of Clinical Suppliers

Valicom is familiar with auditing suppliers for compliance with GCP.  We identify potential risks that could result in compliance problems which could jeopardize your current and future studies. We’ve audited sites, services, and systems essential for GCP compliance, including audits of:

CROs, including site/facility audits
Computer System Validations, including for CTMS, EDMS, and EDC software and services, as well as for custom software implementations
Database services
IVR & IWR services
Call centers
Recruitment services

ICH’s E6(R3) draft guidance emphasizes the importance of the QMS, of defensible risk-based approaches, of data quality and integrity, and of the controls on electronic systems that pertain to data quality and integrity. The R3 draft is expected to supersede 2016’s R2 in 2025.   Valicom can assist you with ensuring, both now and into the future, that your suppliers will meet your requirements and comply with the evolving nature of guidances and GCP regulations.