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.
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
Ensure your trials proceed seamlessly – in full compliance
We enable you to:
- Receive an impartial, independent audit:
for an objective evaluation of your organization's risk and compliance
- Ensure regulatory alignment:
avoid penalties and legal consequences
- Identify potential issues early:
implement corrective actions and preventive measures
- Gain peace of mind:
our comprehensive audits cover all your needs
- Leverage extensive GXP expertise:
benefit from our primary expertise in GCP along with experience in other GXP, including GCLP, GMP, and GAMP 5
Trusted GCP compliance from a world-leading auditor
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.
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.
201 Route 17 North,
7th floor,
Rutherford, New Jersey, 07070,
United States