Built on a long-term experiences of Clinical Trial planning activities in conjunction with eProtocol generation process, ClinFactory/eProtocol offers unparalleled flexibility and performance. The best-of-breed features was designed to simplify your Clinical Trial planning and Protocol generation processes (see ClinFactory/eProtocol).

ClinFactory/eCRF template design

We introduce an innovative semi-automatic eCRF design process based on extended CDISC ODM/Study schema and extended JANUS data model containing Observation Definition catalog (see ClinFactory/eCRF template design).

ClinFactory/electronic data capture (eDC)

A crucial criterion for electronic data capture (eDC) personnel is accuracy and consistence of collected data. This needs a precise observation type definition, an ergonomic user interface with a rigorous validation process. The format for data transport is based on the CDISC/ClinicalData schema. The repository data model is based on “extended” JANUS model which allows on the one hand to stay close to the FDA data mapping conventions and on the other hand to include additional information necessary for automatic eCRF generation process (see ClinFactory/electronic data capture (eDC)).