as required.They form part of the project documentation and are an important element in the ongoing review process for our corporate SOPs. Both our EDC solution and our internal IT environment have been designed to meet the regulatory requirements set forth by FDA 21 CFR Part 11 and FDA Guidance for Computerized Systems Used in Clinical Trials.

Our systems and SOPs undergo a periodic independent 3rd party regulatory-compliance audit; as mandated by our corporate policies. This audit ensures that our data management and biostatistics procedures, systems, and associated documentation and controls comply with regulatory guidelines and industry standards.