The Process
Clinical Ink's experienced design staff works with the sponsor's study team to develop eSource documents that are 21 CFR Part 11 compliant and meet the protocol requirements. Our eSource Designer allows us to quickly create source documents that include protocol specific data points and edit checks in a format that is familiar, easy to use and ensures the timely transmission of clean data to downstream systems. Once developed and validated, the source documents are uploaded to the SureSource™ server where they can be securely downloaded by the research sites.
Working with our partners, Clinical Ink deploys tablet PCs to all sites engaged in the study. Clinical Ink and our partners provide 24/7/365 technical support for both the tablet PCs and study software. Since SureSource™ is capable of running multiple studies both simultaneously and sequentially, tablets remain on site as long as studies are being conducted there. One mobile device handling multiple studies — finally.