Aris Global and Medidata Solutions Partner to Offer Integration of EDC and Safety Reporting
Solution Offers Instant Data Transfer from EDC to Pharmacovigilance & Safety
System to Streamline Patient Adverse Event and Reaction Reporting
NEW YORK, N.Y. and STAMFORD, C.T. - May 12, 2010 - Leading clinical trial technology companies Medidata Solutions (NASDAQ: MDSO), and Aris Global today announced the availability of an integrated solution that provides rapid data-sharing between the Medidata Rave® system for electronic data capture, management and reporting and ARISgTM, a leading 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 costly and time-sensitive burden of collecting and reconciling safety data.
"Like Medidata, Aris Global has long subscribed to the approach of supporting customer choice in best-of-breed clinical trial technology," said Jeffrey Yablon, Vice President, Sales Aris Global. "While Aris Global offers agCaptureTM, 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," he added.
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.
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.
"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," said Glen de Vries, President, Medidata Solutions. "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 the Medidata 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.
About Aris Global
Aris Global (www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. More than 300 life science organizations rely on the company's advanced solutions for maintaining regulatory compliance, managing and mitigating risk, improving operational efficiency and easily sharing information on a global basis.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of hosted clinical development solutions that enhance the efficiency of customers' clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer®), investigator benchmarking and budgeting (Medidata Grants ManagerTM), contract research organization (CRO) benchmarking and budgeting (Medidata CRO ContractorTM), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave®). Medidata's diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.
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