Scope of Good Clinical Practice

GCP compliance is a mandatory requirement for clinical investigators, sponsors, and contract research organizations conducting clinical studies in both EU (implemented as Directive 2001/20/EC) and U.S. markets. Key health monitoring bodies including European Medicines Agency (EMA), FDA and WHO often collaborate and exchange insights on GMP to ensure better human subject protection and clinical data quality. 

GCP expects trial reports from clinics are complete, free from ambiguity, well-organized, and easy to review.   

Requirements of Good Clinical Practice

GCP guidelines are designed to safeguard the human rights of subjects and volunteers in clinical trials, providing assurance of the safety and efficacy of newly developed products. These guidelines also establish standards for the conduct of clinical trials and outline the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors, who are commonly referred to as clinical research associates in the pharmaceutical industry   

Good Clinical Practice audit by Eurofins

Eurofins can deliver GCP audit for clinical institutes globally to fulfill this regulatory requirement. Our professional GCP auditors will provide the audit reports and findings, based on unbiased assessment from document review, clinical personnel interviews and clinic practice observations.  

Why choose Eurofins for your GCP audit?

We possess over 25 years of experience in the pharmaceutical and healthcare industry, supporting customers around the world on their compliance journeys. Our global network of auditors allows us to respond to your requests swiftly with travel costs and time minimized. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver. 

Our GXP audit is accredited for ISO 9001, showcasing our commitment and achievement to quality excellence!

In addition to on-site audit services, thanks to our expertise, we can deliver training and advisory services to better support customers who need extra help in reaching compliance goals.

When working with us, our professional and customer-centric teams assist you along your GCP audit, and provide your GCP audit reports on time.

Auditing activities are compliant with international regulations such as EU, US, Brazilian, Canadian, and more. 

Our certification activities are provided by independent Certification Bodies, separately from any consulting activities. Impartiality is safeguarded by Eurofins Assurance’s relevant policies to avoid conflicts of interest.