GCP Auditing & Inspections.
Keeping you compliant and inspection-ready throughout your clinical trials.

What are GCP Auditing & Inspections?

The need for GCP Auditing & Inspections.

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 of clinical trial activities. GCP Auditing & Inspections are therefore a critical part of that ongoing compliance, reviewing and assessing whether those trial activities adhere to regulatory requirements outlined in the clinical trial protocol and any SOPs or quality programs within the clinical quality management plan (CQMP).

In the EEA, National Regulators perform clinical trial inspections conducted in their territory, and in the UK the MHRA. The EMA’S Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Inspections are usually based on the document compilation within the Trial Master File (TMF).

The audit should therefore provide a fully documented and organised proof of compliance throughout a study that ensures a sponsor is always inspection ready, and in preparation for a Marketing Authorisation Application.

Click here for more information from the EMA on the Good Clinical Practice Inspectors Working Group.

Common areas within a GCP safety audit.

The full scope of all GCP Auditing & Inspections involves different areas within a clinical trial including the study site, third party service providers, and specific systems, but a GCP Safety Audit will typically review the following areas:

  • Safety Management Plan review including processes and execution.
  • Standard Operating Procedures (SOPs) review
  • Serious Adverse Events (SAEs) review.
  • Safety Database validation and review.
  • Aggregate reports and timelines.
  • Internal and external reporting timelines.
  • Report quality.
  • Authority communications.
  • IT systems and backups.
  • Business Continuity Plan.

Click here for more information from the EMA on the Committee for Medicinal Products for Human Use (CHMP).

Why choose Aegisana for your GCP Auditing?

Identifying compliance risk.

A deep understanding of the clinical trial process and its safety objectives allows our Compliance & Auditing team to perform expert GCP safety audits that will identify and assess the potential compliance risks that can jeopardise a study.

We know that during this phase of your product’s development, a reliable service provider is critical to ensuring all the safety aspects of your Clinical Trial Documentation are covered and there are no regulatory barriers to its success.

Confidence during development.

We aim to give you the peace of mind and confidence that all your trial safety processes are fully reviewed, and any anomalies or deficiencies are clearly and easily communicated in our audit findings.

Whether you are taking a conventional approach to monitoring or a using Risk-Based Monitoring (RBM) system, our quality experts can tailor their auditing plans to accommodate your requirements.