Quality Assurance Consultancy supports organizations in conducting clinical studies for regulatory compliance.

Serving as third-party quality assurance (QA) auditors under the U.S. Food and Drug Administration (FDA)/International Conference on Harmonisation (ICH) GCP, our specialists serve as the independent review of clinical studies to improve the quality of the reports you submit to the FDA.

We operate on behalf of the sponsor, or the clinical research organization (CRO), providing the following services:

  • CRO/site qualification
  • Case report form (CRF) development and design
  • Investigators brochure (IB) audit
  • Investigational new drug (IND) submission review
  • Institutional review board (IRB) audit
  • Source documents review
  • Database audit
  • Bioanalytical data and report audits
  • Trial master file review
  • Clinical reports audits
  • New drug application (NDA) submission review
We also operate on behalf of individual clinical sites, offering the following services:
  • Gap analysis
  • Coordinator and principal investigator training
  • IRB audits
  • Pharmacy audit
  • Clinical laboratory audit
Additionally, ourĀ GLP-Compliant Archiving Solutions provide safe and secure long-term archival of your clinical study data, including paper and electronic media.