Compliance

Since inception, QDS has completed hundreds of clinical trials successfully, and has had the opportunity to provide service for multiple commercially-available products.  We are very proud of our quality record in that we have never failed a Quality Control Audit, and that both Sponsor and Site FDA audits have been without issue or 483s. 

FDA Audit History

• 2008 – 510K Submission; CE-mark and FDA approval
  • No 483s
• 2006 – FDA Audit of QDS
  • No 483s
• 2005 – SNDA Submission global CNS
  • QDS – CDM pivotal trial with QDS-EDC
    • No 483s
• 2004 – SNDA Submission
  • QDS – CDM pivotal trial with QDS-EDC
  • Site Audits
    • No 483s

Approximately 85% of our business is from repeat clients.  We believe this speaks volumes with regard to quality, value, and our high commitment to customer satisfaction.  QDRx, QDS’ proprietary e-Clinical System, is 21 CFR-compliant and fully validated and documented, with audit trails in all functions.