Sentrx Enhances Technology Offerings with Medidata Rave Safety Gateway for Improved Safety and Adverse Event Capabilities for Life Science Clinical Trials
Sentrx, a specialty provider of pharmacovigilance services and solutions, announced today that they will immediately begin to offer clients the ability to integrate their commercial safety system with the Medidata Rave® electronic data capture and clinical data management platform via its Safety Gateway module. The offering will provide clients the ability to improve their safety and adverse event processing through a joint collaboration between Sentrx and Medidata Solutions, a leading global provider of SaaS-based clinical development solutions.
The Medidata Rave Safety Gateway product can communicate directly with commercial safety systems by leveraging the International Conference on Harmonization standard for electronic transfer of safety data via E2B standards.
Using the combined expertise of Sentrx and Medidata, clients can very quickly eliminate the need for duplicate data entry as well as streamline safety reporting. Sentrx leverages the Rave Safety Gateway module to automatically transfer safety-related data from Medidata Rave into its Sentrx SÄPh (Specialized Access to Pharmacovigilance Hosting) Solution.
“Efficient data integration is a critically important, enabling capability for organizations seeking robust analytics and accelerated clinical decision-making. Now, Sentrx and Medidata have made that capability easy to obtain, implement and manage on a continuous basis,” said Charles Saldarini, CEO of Sentrx.
Sentrx SÄPh is a regulated, ASP-based approach to drug safety database management, specifically engineered to support power users of safety systems. It includes the implementation, configuration, validation and continuous support and management, all of which are supported by a paperless adverse event management workflow developed by Sentrx. Combined, these services can create a completely compliant drug safety adverse event management process that includes all the supporting technology components. SÄPh also provides high-speed executions managed by highly experienced experts who have conducted over 100 safety system implementations.
Medidata Rave is the industry-leading system for capturing, managing and reporting clinical research data, designed to help life science companies optimize their research investments by efficiently streamlining the clinical trial process. A single platform supporting both electronic data capture (EDC) and clinical data management system (CDMS) functionality, Medidata Rave has the flexible design to support the breadth of any organization's clinical processes, as well as the unique aspects of individual clinical trials. With Safety Gateway, sponsors can greatly improve the accuracy, speed and visibility of their SAE collection and communication process, yielding significant savings in time and resources.
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Wade Weinzetl |
