Adamas Consulting Brochure
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Contact Us
Europe - Tel: +44 (0)1344 751 210
US and Canada -Tel: +1 919 294 4162

Clinical Auditing Services

Adamas Consulting provides a full range of clinical audits from phase I to phase IV studies on an international basis. Following each audit, comprehensive and confidential reports and audit certificates are produced according to Adamas Consulting standard operating procedures or client specifications. Clinical Audits encompass all aspects of the clinical development process:

  • Trial Master File Audits - Comprehensive review of essential documents according to ICH GCP, Directive 2001/20/EC and client SOPs.

  • Investigator Site Audits - Audits of pivotal or supportive studies involving single or multiple investigator sites on a worldwide basis.

  • Phase 1 Unit Audits - Review of facilities, equipment, procedures and personnel, either pre-study or during study conduct.

  • CRO and Clinical Laboratory Audits - Pre-contractual audits, evaluation as preferred service providers or audits involving ongoing projects.

  • Database Audits - Audit of a sample of data from a locked database according to either the client or Adamas Consulting SOPs.

  • Clinical Report Audits - Audits of clinical reports against client SOPs and ICH GCP requirements.

Contact Adamas Consulting by email or on +44 (0)1344 751 210 to discuss your individual requirements.

 

Excellent, considering the audience, their responsibilities and the dryness of the subject matter.
J.U. – Operations Manager – European CRO