A comprehensive range of GCP audit services
We provide a wide range of GCP audits, covering study audits and qualification audits, including:
- Trial master file audits
- Investigator site audits
- Phase I unit audits
- Vendor audits
GCP ensures the ethical and scientific quality of clinical trials. In a landscape marked by stringent regulatory requirements, organizations face the challenge of maintaining compliance while efficiently managing resources.
We provide risk-based GCP compliance audits for Phase I-III clinical trials, pinpointing potential non-compliance areas to ensure strict adherence to regulations and save organizational resources.
We provide a wide range of GCP audits, covering study audits and qualification audits, including:
We enable you to:
for an objective evaluation of your organization's risk and compliance
avoid penalties and legal consequences
implement corrective actions and preventive measures
our comprehensive audits cover all your needs
benefit from our primary expertise in GCP along with experience in other GXP, including GCLP, GMP, and GAMP 5
As the global benchmark for quality and integrity, we offer a hands-on, straightforward approach to GCP compliance audits. Our extensive operational and audit experience, and broad network of subject matter experts ensure a comprehensive audit process, tailored to the specific needs of your clinical trials.
Beyond audits, we provide tailored consultancy, training and SOP support to keep you inspection-ready under ICH E6(R3).
Our experienced audit team offers broad European coverage, conducting thorough audits across study phases. With a focus on GCP regulations – our team excels in qualifying and evaluating compliance for both sites and vendors.