Brussels Region has awarded EORTC with an Innoviris grant to support the development and validation of its Vista Trials 2.0 clinical trial data management system (CDMS). With this financial support, the new version of the Vista Trials toolset will add new functionalities, including blind study management, CDISC Study Data Tabulation Model, electronic Patient Reported Outcomes and the use of medical dictionaries (WHO, MedDRA). Vista Trials 2.0 is scheduled to be released in Q4 2017.
Vista Trials is a unique, fully web-based CDMS that integrates all functionalities needed for the management of modern clinical trials. An innovative platform, it was developed in collaboration with ECRIN under the ECRIN-IA FP7 project, and offers a flexible system to adapt to most clinical study settings. Its functionalities include remote data capture, study and eCRF design, dynamic eCRF, subject inclusion and randomization, manual and automated edit checks and queries, audit trail, electronic signature, access rights & user management, CDISC Operational Data Model import and export.
The pilot version of VISTA Trials 1.0 was released in May 2016, and validated under the FDA 21 CFR Part 11. It is currently used in EORTC international clinical trials. Version 1.0 of Vista Trials will be deployed early 2017.
Vista Trials is the successor of the Vista suite, developed in the 1990’s as EORTC’s answer to the lack of high-quality, affordable CDMS that meet the requirements set by the European Medicine Agency, US Food and Drug Administration and Good Clinical Practice, and comply with Clinical Data Interchange Standard Consortium (CDISC), to support academic clinical research. Today, some 210 EORTC clinical studies are running Vista, and 370 clinical sites are using the Vista remote data capture module. Vista has been used in several drug registration clinical studies and has been successfully audited by health authorities from several countries and large pharmaceutical companies.
For more information about Vista Trials functionalities, visit www.vistatrials.org