Clinical Quality

Audits

Risk-based GCP Audit Programmes

An Audit programme is a set of one or more audits planned for a specific time frame and designed for a specific purpose. They are a vital part of the Quality Management System and should be developed following a risk based approach.

We can assist you in the development and maintenance of your GCP audit programmes by carefully selecting the risk criteria that align with the unique aspects of your clinical trials or programs and ensure risk proportionate and effective auditing activities.

Study Audits

As part of their trial specific quality programs, Sponsors may plan and conduct study related audits such as:

Investigator Site Audits

eTMF Audits

We can prepare, conduct and report those audits on your behalf, with the highest quality and ensuring value added to the Sponsor.

We can also support your auditing teams by performing audit report peer review or independently support your auditees, internal or external, with their audit CAPA writing.

Clinical Quality

Audits

Risk-based GCP Audit Programmes

Study Audits

Other Services