FOR IMMEDIATE RELEASE
New EDC-Based Tool Designed to Improve Speed and Reduce Error in TransferringSerious Adverse Event Information from Investigational Sites to Safety Reporting Systems
NEW YORK, N.Y. – December 3, 2009 – Medidata Solutions (NASDAQ: MDSO), a leading global provider of hosted clinical development solutions, announced the introduction of Rave Safety Gateway, the newest extension to its Medidata Rave® electronic data capture (EDC) and clinical data management (CDM) solution. Rave Safety Gateway provides clinical research sponsors and contract research organizations (CROs) with a more efficient and accurate solution to perform the time-critical task of collecting and transmitting serious adverse events (SAEs) and related data from sites to safety reporting systems.
Global regulatory agencies enforce stringent guidelines for timely reporting of SAEs by sites and sponsors during clinical trials. Today’s process of collecting complete and accurate SAE information relies heavily on multiple exchanges including phone conversations, paper forms and faxes between sites and sponsors. Safety teams must then manually enter all SAE information into a safety reporting system, even though much of this data has already been captured by sites in an EDC system. In addition, sites must bear the burden of communicating this information to sponsors via a separate paper process. These laborious and redundant manual efforts are further compounded by the need to reconcile clinical and safety data at the end of a trial.
Medidata Rave Safety Gateway addresses these inefficiencies by providing built-in functionality that automatically transmits safety case data entered at sites to sponsors’ safety reporting systems using the International Conference on Harmonization (ICH) industry standard E2B file format. By doing so, both sites and sponsors can leverage efforts already put forward in entering safety related data into the EDC system, thus significantly reducing the burden of collecting and reconciling safety data.
“The introduction of Rave Safety Gateway offers our clients the opportunity to achieve significant efficiency improvements by streamlining their safety data collection and transmission processes,” said Glen de Vries, president of Medidata Solutions. “Rave Safety Gateway enables our customers to build a fully electronic, standards-based process to submit all SAE-related data captured in EDC to the safety system of their choice with minimal effort. The single source of data maintained through this end-to-end eClinical process reduces the reconciliation efforts between safety and clinical databases during the life cycle of a study.”
Through a unified, integrated process to collect and extract both clinical and SAE data in a single system, Rave Safety Gateway leverages Rave’s robust data management capabilities to improve SAE data completeness and accuracy. Safety teams now gain full visibility into all relevant clinical data and query sites directly through the EDC system. This common view of data sets shared by the safety team, data management team and investigational sites greatly increases the speed and efficiency of safety case triage, delivering significant savings in time and cost. Sponsors gain further efficiencies with reduced reconciliation efforts between safety and clinical databases and superior audit capabilities following the full data transmission history as cases are updated.
Rave Safety Gateway has been successfully tested with major safety reporting systems and is offered as a module within Medidata Rave 5.6.3.
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 Manager™), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor™), 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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Susan McCarron
Lois Paul & Partners
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