Services

Primary business areas are clinical quality assurance, including GCP audits and clinical quality system evaluation.

Assistance is offered in establishing clinical quality systems including preparation and re-view of SOPs.

Training in ICH GCP, other regulatory requirements and client SOP in connection with es-tablishment of a quality system for the conduct of clinical trials.

Co-audits with sponsor auditor e.g. as part of the training of sponsor auditors are pro-vided.