Quality Control and Assurance

img06Quality Control/Assurance (QC/QA) lays the foundation of good clinical research, and with the ever- increasing regulatory stringency towards drug development, demands quality of the highest level. ClinSoft recognizes the importance of quality in all aspects of our clinical research and to this end have a global quality assurance (QA) group.

Our QA team consists of senior auditors with expertise in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).

 

Audit Services for :

  • Investigator Sites
  • Protocols
  • Master files
  • Institutional Review Boards
  • Standard Operating Procedures

 

Validation Services for :

  • Computer Systems
  • Databases
  • SOPs

 

Specific QA of Study deliverables including :

  • Protocols
  • CRFs
  • Clinical Study Reports
  • Study Files
  • Tables and Listings
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