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NEW YORK, N.Y. – December 3, 2009
Medidata Solutions, a 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 between sites and sponsors. Safety teams must 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.