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Joint customers benefit from automatic transmission of serious adverse event data collected in Medidata Rave@ EDC/CDM system to EXTEDO drug safety solution

Mon, 03/19/2012 - 4:45am
The Associated Press

NEW YORK--(BUSINESS WIRE)--Mar 19, 2012-- Medidata Solutions (NASDAQ: MDSO) has further expanded its Partner Program by naming EXTEDO, provider of regulatory information management software and service solutions, a Medidata Technology Partner. EXTEDO created an integration that utilizes Medidata Rave Safety Gateway to transfer critical safety data from Medidata Rave, a leading system for electronic data capture (EDC), clinical data management (CDM) and reporting, into its PcVmanager drug safety management solution. With the integrated solution, research sponsors can more efficiently and quickly access and manage safety information throughout the clinical development process.

-- "Management of safety data is one of the most critical and complex pieces of the clinical research puzzle, and sponsors need to ensure that every system they put in place is not only helping to control costs and increase efficiencies, but also minimize risk," said Glen de Vries, president of Medidata Solutions. "With this integration, EXTEDO has invested in more streamlined clinical trials and faster safety reporting for the sponsors relying on both Medidata and EXTEDO solutions." Medidata Rave Safety Gateway is a secure, configurable electronic data capture to-safety-system interface that transmits safety case data, entered by sites into Medidata Rave, automatically into sponsors' safety reporting system using the International Conference on Harmonization (ICH) industry standard E2B file format. Real-time transfers of this data from Rave into the EXTEDO PcVmanager-which enables classification, creation, reviewing, submission and maintenance of pharmacovigilance data and serious adverse event (SAE) reports-allows joint customers to benefit from enhanced tracking and reporting capabilities earlier in the clinical trial process.

-- "Our customers expect us to provide premier solutions that enable streamlined safety and compliance reporting, and this partnership with Medidata further enhances our ability to deliver on that promise," said Tore Bergsteiner, founder and CEO of EXTEDO. "The integration with Rave Safety Gateway offers our pharmaceutical, biotech and medical device customers a fully electronic process to submit all SAE-related data to our safety reporting system with better quality.

The solution is designed to minimize required reconciliation between safety and clinical databases, helping sponsors ensure compliance, reduce risk and better prepare for FDA submission." Customers who are interested in learning more should attend eRA 2012, the annual EXTEDO user group meeting and electronic regulatory affairs conference, taking place March 20-21, 2012 in New Orleans.

The Medidata Partner Program currently has 18 Technology Partners, solution providers that have leveraged Medidata interoperability tools to integrate Medidata products with third-party solutions. Rapid data sharing across systems further streamlines and enhances the end-to-end clinical process for joint customers.

About EXTEDO EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. EXTEDO's focus is on optimizing our client's eRegulatory business process. Our enabling technology, the EXTEDOsuite, is unique in that it covers the complete regulatory landscape including: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labelling Management and Document Management. Today EXTEDO serves over 700 customers in 57 countries including the EMA and more than 25 Regulatory Authorities worldwide.

Connect with Medidata: -- Read our blog, Geeks Talk Clinical -- Follow us on Twitter: @Medidata -- Find us on LinkedIn -- Tweet this: .@Medidata recognizes @EXTEDO as Medidata Technology Partner for EDC-safety system integration http://bit.ly/FOXi6L About Medidata Solutions Worldwide Medidata Solutions is a leading global provider of SaaS clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced solutions lower the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

CONTACT: Lois Paul and Partners Susan McCarron, 617-986-5767 Susan_McCarron@lpp.com KEYWORD: UNITED STATES EUROPE NORTH AMERICA CANADA NEW YORK INDUSTRY KEYWORD: TECHNOLOGY SOFTWARE HEALTH BIOTECHNOLOGY MEDICAL DEVICES PHARMACEUTICAL SOURCE: Medidata Solutions Copyright Business Wire 2012 PUB: 03/19/2012 08:30 AM/DISC: 03/19/2012 08:30 AM http://www.businesswire.com/news/home/20120319005407/

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