Theorem Clinical Research Saves Sponsors Time, Resources and Ensures Quality Through Improved Safety Data Collection and Transfer Capabilities

Published: Jun 05, 2013

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(King of Prussia, PA; June 05, 2013) — Theorem Clinical Research, which continues to improve its ability to help sponsors optimize trial conduct, recently expanded its partnership with Medidata by obtaining accreditation for Medidata Rave Safety Gateway, an innovative EDC-to-safety-system interface.

“By improving the speed and accuracy of safety data collection and transfer, we help sponsors save significant time and resources while improving quality,” said Mark Penniston, Theorem’s senior vice president for clinical analytics.

“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."

Theorem has more than 100 Medidata Rave Certified Study Builders and is one of the leading contract research organizations holding multiple accreditations across the Medidata platform. As a Medidata Services Partner, Theorem 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 a unified approach to patient data and randomization and trial supply management (RTSM) — shortening the time spent on subject randomization, treatment dispensation and clinical data entry and reporting.

• Medidata Rave Targeted SDV, which enables Theorem to execute targeted, risk-based source document verification to provide more efficient monitoring services.

“Our team is focused on driving quality and efficiency in combination and medical device trials,” Penniston said. “By leveraging technology with our deep expertise in biopharmaceuticals, clinical analytics and diagnostics, we help sponsors reach a successful conclusion to their trials quickly and cost-effectively.”

About Theorem Clinical Research

Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM.

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