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Clinical Trial Audits
 

Rita Walt Consulting GmbH

     

  In-House Audit (Trial Master File): Comprehensive review of essential documents according to ICH-GCP and client SOPs.

  Investigator Site Audit: Comprehensive review of essential documents according to ICH-GCP and client SOPs, Source Data Verification, inspection of trial-specific facilities/equipment and record of drug accountability.

  Phase I Unit Audit: Review of facilities, equipment, procedures and personnel, either pre-trial or during trial conduct.

  Audit of clinical laboratories/pharmacies: Thorough evaluation of both organisation and personnel, including SOPs, equipment, investigational medicinal product (IMP) storage and record keeping.
  International System Audit: Procedures and practices involved in the conduct of clinical trials, including monitoring, adverse event reporting, supplies distribution and data handling.
  Computer System Validation Audit (CSV): The CSV audit is to assess good computer system management practice, and to verify that the computerised system is validated according to regulatory requirements such as 21 CFR part 11. Review of all procedures, software development documentation, operational documentation, assessment of computer room hardware and network design and management.
  Database Audit: Audit of trial database against CRFs. Includes thorough review of all data handling systems, data clarification and consistency, coding and data entry procedures.
  Clinical Report Audit: Audits of clinical reports against protocol, CRF, database, client SOPs and ICH-GCP requirements. Includes a review of tables and listings.
  Due-diligence Audit of Contract Research Organisation (CRO) prior to trial placement: Audit of organisations or corporations which have entered into a contractual agreement with a sponsor.
   

Albert Schweitzer Hospital, Lambarene

Mbuji Mayi, Congo Discussion
with Principal Investigator

   

Laboratory of an investigational
site in Kolkata/India

Newly built Clinical Trial Unit
in Banfor / Burkina Faso

   

Prior to refurbishment in early 2010

CTU Site Iganga / Uganda, December 2010

   

State-of-the-art Clinical Trial Unit
in Banfora / Burkina Faso

Clinical Trial Unit attached to the Aga Khan
University Hospital, Karachi - Pakistan

   

Clinical Trial Unit attached to the Aga Khan
University Hospital, Karachi - Pakistan

Investigator Site in Mali

 

Investigator Team at CVD, Mali (part of team)