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Medidata, Aris Global To Jointly Offer Integrated EDC, Safety Reporting

Medidata Solutions and Aris Global have introduced an integrated solution that provides rapid data-sharing between the Medidata Rave system for electronic data capture (EDC), 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, reducing risk, redundant data entry and eliminating the need of collecting and reconciling safety data.

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.

Medidata Solutions claimed that 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.

With a collective customer base of several hundred large and mid-market pharmaceutical, biotechnology and medical device companies, academic research institutions and CROs worldwide, Medidata and Aris Global anticipate a number of sponsors will take advantage of this integrated solution.

Jeffrey Yablon, vice president of sales at Aris Global, said: “Like Medidata, Aris Global has long subscribed to the approach of supporting customer choice in best-of-breed clinical trial technology. While Aris Global offers agCapture, a proven 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 and offers significant advantages to pharmacovigilance teams.”

Glen de Vries, president of Medidata Solutions, said: “To achieve optimal efficiencies across clinical research processes, sponsors require, and are demanding, the ability to easily implement the most advanced technologies in alignment with their strategic goals.

This partnership is further proof that ‘one-size-fits-all’ or ‘multiple legacy systems’ approaches are no longer valid in our market. Sponsors are savvier, the pressures on operations are greater and there is no excuse for integrations that are less than seamless.”

The Medidata-Aris Global solution also marks Aris Global’s membership into Medidata’s technology partner program. Since its introduction in June of 2009, the program has grown to include eight independent technology vendors that offer solutions supporting data sharing with Medidata products in order to streamline and enhance the end-to-end e-Clinical process.

Aris Global is a provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information.

Medidata Solutions is a global provider of hosted clinical development solutions that enhance the efficiency of customers’ clinical development processes and optimize their research and development investments.