Cleveland-based Datatrack said that Version 4.0 of its electronic data capture (EDC) product suite represents significant advancements in software engineering and architecture from the most experienced developers in the EDC industry.
The integrated study design architecture is said to allow for an almost effortless push button amendment or mid-study change process.
Amendments are commonplace because of the dynamic nature of clinical trials. The organized and premeditated structure of EDC clinical trials is what gives technology the advantage of speed over paper-based methods, but this requirement becomes challenging when multiple alterations to a study design necessitate commensurate changes to the eventual database.
Study amendments are frequently perceived to be a major difficulty of all EDC systems. According to Datatrak, Version 4.0 has solved this problem by automatically linking any changes to the electronic case report form (eCRF) directly to an appropriate reconfiguration of the database in a manner that is completely transparent to the user.
Additionally, because of its open architecture, Version 4.0 will be capable of converting clinical trials begun with another EDC product over to Datatrak EDC.
