Documentation of studies made simple
„Clinical trials without paper“ – with this vision iOMEDICO started the development of a electronic data capturing system in 1993 as pioneer and innovator. Since then the iOstudy office edc has been continuously developed further, amended based on internal and external requirements and improved.
The web-based system is customized for clinical projects, validated and operates according to the guidelines of FDA 21 CFR Part 11. The international standards of the Clinical Data Interchange Standards Consortiums (CDISC) are implemented throughout. Standardized processes from capture via storage through to external exchange of data.
|Customized development||All projects profit from over 20 years of experience in eCRF design and our indication specific expertise in the conduct of oncological study projects. The study protocol is developed in close consultation with all project team members and implemented in a custom-fit way.|
|Fast capture||Due to the modular design, the eCRF is ready for use and validated shortly after finalization of the study protocol. User-friendly operating controls and online-help ensure simple and timely data capture whilst adhering to high quality criteria.|
|Check||Data entry is monitored by integrated plausibility and completeness checks. Fast and accurate monitoring is supported visually. For quality assurance, the data are reviewed systematically on a regular basis.|
|Simple checkse||The documentation of the data in the study center is carried out and immediately quality controlled: Plausibility and completeness are checked automatically. A fast and precise monitoring is supported visually, protocol deviations are prevented and on-site monitoring reduced.|
|Timely analysis||The data is retrievable at any time, can be used for the compilation of listings and reports and accessible for biometric evaluations. A fast access to crucial information assures transparency for all project members.|
|Targeted management||A targeted exchange of information is the basis to manage projects proactively. Status reports allow an optimal overview during the course of the project on a daily basis allowing a fast reponse to current events.|