EDC – Paperless data capturing

“Paperless clinical trials” – with this vision, iOMEDICO started out to become a pioneer in the development of an electronic study documentation system: paperless and quality assured. It is still the centrepiece of our digital applications, continuously developed and adapted to regulatory changes.

EDC – Paperless from the very beginning

Back in 1993, when clinical data was still primarily recorded on paper, iOMEDICO began to develop its own electronic data capturing system (EDC) for trial data. It was used for the first time in a clinical trial in 1994, and since then continuously developed further and adapted to regulatory changes.

Today’s version of the iOstudy office edc is based on long-standing oncological expertise and more than 25 years of experience in eCRF design. It was developed together with and tested by our users.

An EDC solution which meets the demands for an efficient, quality assured and fast documentation.

 

ITS MOST PROMINENT FEATURES

  • Webbased application
  • Automatic checks for plausibility and completeness
  • CDISC conformity
  • In line with FDA 21 CFR Part 11 guidelines and Annex 11 of the EU GMP manual
  • E2B export and SAE reporting directly from EDC
  • Efficient, visually supported monitoring, to enable Risk Based Monitoring
  • Export options fitting all common file formats