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 Clinical Ink™ 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. At the end of the study, the tablets are either picked up or readied for use in further studies at the site.