Clinical trial technology companies Medidata Solutions and Aris Global announced the availability of an integrated solution that provides data-sharing between the Medidata Rave® system for electronic data capture, management and reporting and ARISg™, a solution for pharmacovigilance and clinical safety. The solution leverages Medidata’s Rave Safety Gateway, a configurable EDC-to-Safety system interface, to automatically transmit safety-related patient data collected in Medidata Rave directly into ARISg to help reduce risk, redundant data entry and eliminate the costly and time-sensitive burden of collecting and reconciling safety data.
“While Aris Global offers agCapture™, an EDC solution, we also see the value in giving customers the opportunity to leverage the Rave Safety Gateway to address their critical business challenges. The combined use of ARISg and Medidata Rave, leveraging Rave Safety Gateway, addresses the time-sensitive and safety-critical process of alerting regulatory agencies to potential safety events,” said Jeffrey Yablon, Vice President, Sales Aris Global.
A key purpose of clinical trials, as well as being a major obligation of the sponsor, is to monitor patients for serious adverse events (SAEs) and to collect and transmit reports in a timely manner. Even today, much of the collection of that data takes place outside other automated processes in a clinical trial, such as EDC systems like Medidata Rave. The traditional process involves phone conversations, paper forms and faxes between sites and sponsors, as well as manual keying of data into the sponsors’ safety system like ARISg, which helps collect, code, analyze and submit the information to regulatory agencies and license partners on a timely basis.
By instantly transferring safety-related data from the Medidata Rave EDC system to the ARISg safety reporting system, this solution helps eliminate duplicative entry, reduce SAE reconciliation efforts and chances for errors and expedite reporting time.