Quality Assurance

Audits are reviews of documents and facilities, as well as interviews with personnel involved in certain tasks relevant for clinical development. These are mandatory according to ICH GCP, and besides this, a well-established QA method.

The following types of audits can be performed based upon your request:

  • routine audits in the context of a clinical trial
  • for cause audits
  • system related audits
  • service provider & vendor qualification audits
  • clinical document (protocol, informed consent documents, Trial Master Files (TMF), Clinical Study Reports, etc.) audits.

The audits can be performed at clinical trial sites, CROs, service provider facilities and client’s facilities.

We can also support you in developing, implementing and managing audit programs.