Theorem Clinical Research has expanded its partnership with Medidata by obtaining accreditation for Medidata Rave Safety Gateway, an EDC-to-safety-system interface.
 
“The Medidata Rave Safety Gateway is just the latest in a series of enhancements implemented by our pharmacovigilance team,” said Marc Hoffman, Theorem’s senior vice president for biopharmaceutical development. “It dramatically improves case processing and reconciliation and is particularly valuable when significant adverse event processing is required as well as on stand-alone functional service provider engagements.”
 
“We are pleased to see Theorem strengthen its adoption of the Medidata platform to enhance its customers’ safety data transfer processes for improved accuracy and new efficiencies,” said Steve Heath, vice president of channel sales at Medidata. “This accreditation will serve to support Theorem’s strong expertise and global reputation for successfully ensuring smooth trials.”
 
As a Medidata services partner, Theorem now holds accreditation in: Medidata Rave, which enables it to independently deliver a full suite of Rave services including study build, end user training, data migrations and advanced reporting; Medidata Balance, which enables Theorem to provide sponsors with patient data and randomization and trial supply management (RTSM); and Medidata Rave Targeted SDV, which enables Theorem to execute targeted, risk-based source document verification for monitoring services.