Our Clinical Discovery Platform (CDP) has been validated and verified (by an independent 3rd party organization) to be in compliance with the FDA's regulations on electronic signatures and electronic records (21 CFR Part 11).  In addition we make available to our clients,  a comprehensive summary which documents our ability to meet all of the requirements set forth in the FDA's Guidance for Computerized Systems Used in Clinical Trials.

We've already done the "heavy lifting" in order to meet the current and ongoing federal regulations. As a result, sponsor requirements for demonstrating compliance are reduced substantially.  We're proud of our investment in assuring system compliance, accuracy, and reliability and look forward to sharing the benefits with you:

• Complete development documentation

• Detailed unit and system test cases

• Input/output verification - [traceability analysis]

• SOPs, guidelines, work instruction