PPD Partners With Microsoft

By Alison Lee Satake, posted Jul 27, 2010

Microsoft Corp. entered into an agreement with Wilmington-based contract research organization PPD Inc. to implement a new technology for managing risk evaluation and mitigation programs mandated by the U.S. Food and Drug Administration.

The technology, which is based on Microsoft Amalga Unified Intelligence System (UIS), a data aggregation platform that gives healthcare professionals access to information and Microsoft HealthVault, a personal health application platform that lets consumers gather, store and share health information online, will improve efficiency in managing FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs.

REMS programs are required by the FDA for certain marketed drugs to ensure that the benefits of a product offered to consumers outweigh the risks. They can include elements to assure safe use, communications plans and medication guides, which all require assessment.

“We’re excited to collaborate with PPD to deliver a new REMS solution for the biotechnology and pharmaceutical industry,” said Steve Shihadeh, general manager, Microsoft Health Solutions Group in a press release. “We look forward to seeing the positive impact our solution brings to PPD clients as they manage the prescription drug life cycle.”

When completed, this first-of-its-kind technology solution will provide biopharmaceutical companies with a long-term system for managing operational components of REMS programs while tracking large amounts of information collected from multiple sources, including the patient, healthcare provider and pharmacy.

“Efficient, effective REMS programs require real-time access to information by multiple internal and external stakeholders,” said Mike Wilkinson, executive vice president and chief information officer for PPD in a press release.

It also will integrate PPD’s strategic, scientific, operational and regulatory capabilities in designing and implementing comprehensive REMS and risk management programs with Microsoft’s global software development expertise.

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