Good Clinical Practice (GCP) audit
Good Clinical Practice (GCP) refers to compliance to international ethical and scientific quality standards for the design, conduct, recording, and reporting of clinical trials involving human subjects. GCP aims to protect the rights, safety, wellbeing and data integrity of human taking part in clinical trials. It also looks at credibility of data from clinical trials.
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 minimised. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver.
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.
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