OpenClinica

Electronic Data Capture System for the management of eCRFs, Pathology Registries and Rare Disease Registries

DataRiver has developed an Electronic Data Capture (EDC) system based on the validated OpenClinica web platform, that allows you to manage eCRFs, rare disease and pathology registries on both PCs and Tablets. This system is compliant with international clinical data management regulations and guidelines.

Features

Trough a customized notifications system and a platform accessibility open to mobile devices, users can always be updated in real time on the progress of the clinical studies they are following.

Management of clinical trials

The OpenClinica web platform allows the management of clinical trials of Phase I – IV drugs, observational studies and studies on medical devices.

Online randomization integrated in the eCRF system

Randomization is automatically managed by the eCRF system and allows patients to be distributed in a potentially unlimited number of therapy arms. Randomization can be performed from a preloaded list and provides the possibility of balancing the distribution of patients on the basis of the stratification variables and groups (clusters) set for the protocol.

Quick implementation and release of the eCRF

The use of a library of modular and editable Case Report Form available on OpenClinica allows a quick implementation and release of the eCRF.

Unified and real-time vision of the clinical study progress

The Web Platform displays the patient enrollment trend and the data collection progression of the clinical trials running on the platform

Management of rare disease and pathology registries

A customized version of OpenClinica has been designed for the management of rare disease and pathology registries. The Web platform can be further customized to meed the specific needs / requirements of a single project and of the specific therapeutic field.