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  6. Adamas Consulting LLC

Adamas Consulting LLC

3434 EDWARDS MILL RD RALEIGH, NC 27612 Get Directions

(919) 341-3341

www.adamasconsulting.com

vaska.tone@adamasconsulting.com

Business Info

  • Founded 2010
  • Incorporated CA
  • Annual Revenue $592,900.00
  • Employee Count 6
  • Industries Business Consulting, Nec
  • Contacts Patricia Fitzgerald

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Company Summary


ADAMAS Consulting is an international consultancy providing a full range of independent GCPGLP and GMP Quality Assurance audits and GPVP services on a global basic
Studies, service providers and systems are audited against international and national standards, namely ICH GCP, the Clinical Trial Directive 2001/20/EC, GCP Directive 2005/28/EC and FDA 21 CFR. All of our Consultants carry professional indemnity insurance.

Following each Clinical Quality Assurance audit, comprehensive and confidential reports and audit certificates are produced according to ADAMAS Consulting standard operating procedures or client specifications. Clinical Quality Assurance audits encompass all aspects of the clinical development process: Trial Master File Audits; Investigator Site Audits; Phase 1 Units; Clinical Research Organisations; Clinical Laboratories; Database Audits; System Audits; QMS Gap Analysis; Pharmacovigilance Audits; Biometrics Systems Audits; and Clinical Study Report Audits.
In addition, ADAMAS Consulting provides advice and training on all aspects of ICH GCP, the Clinical Trial Directive 2001/20/EC, GCP Directive 2005/28/EC and FDA 21 CFR

ADAMAS Consulting also provides a comprehensive Computer System Validation (CSV) audit service in all stages of the life cycle of a computerised system. The CSV audit assesses good computer system management practice, and verifies that the computerised system is validated according to regulatory requirements such as 21 CFR part 11 and ICH GCP. ADAMAS Consulting provides a positive and pragmatic service that is of optimum benefit to the auditee.

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