GCP Compliance & Auditing
Compliance services for clinical projects.

What is GCP Compliance & Auditing?

The European Medicines Agency (EMA) defines Good Clinical Practice (GCP) as ‘An international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects.

Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, and that clinical-trial data are credible.’.

Click for more information from the EMA on Good Clinical Practice.

To comply with regulatory requirements, it is essential that both clinical trial sponsors and third parties participating in the process create and maintain a thorough and well-documented audit trail.

This trail should cover the entire spectrum of clinical trial activities, including the planning, execution, oversight, analysis, and communication, involved with investigational medicinal products or devices.

Supporting sponsor GCP Compliance & Auditing requirements.

Our GCP Compliance & GCP Auditing & Inspections services focus on the safety activities within your clinical trial, backed by experience and expertise, and a clear and transparent approach.

Our robust Quality Management System (QMS) can easily and efficiently adapt to your study needs, to ensure compliance, and through good communication, reliability, and trust, we aim to build a successful and strong strategic partnership that can develop beyond your clinical trials across the whole product life cycle.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.