PPD and Microsoft have signed an agreement to jointly implement a technology solution designed to improve efficiency in managing FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs.
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PPD and Microsoft said that the technology will be based on Microsoft Amalga Unified Intelligence System (UIS) and Microsoft HealthVault.
Microsoft said that its UIS is a data aggregation platform that gives healthcare professionals access to the information they need when they need it, whereas Microsoft HealthVault is a personal health application platform that lets consumers gather, store and share health information online.
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.
PPD and Microsoft claimed that the centralised platform based on Microsoft Amalga UIS and HealthVault is expected to provide an easy-to-use interface for physicians, pharmacists and patients involved in REMS. It will also feature intuitive navigation and a high level of customization to provide clients greater control of their REMS programs.
Lori Eberhardt, vice president of global late stage research for PPD, said: “Our clients rely on our expertise in delivering comprehensive risk management programs, which are critical to ensuring patient safety.
“Whether we are working with clients to develop and manage REMS programs to assure safe use or developing a virtual training curriculum, this platform is an efficient solution to connect, manage and track all components of REMS programs.”
Steve Shihadeh, general manager, Microsoft Health Solutions Group, said: “We’re excited to collaborate with PPD to deliver a new REMS solution for the biotechnology and pharmaceutical industry.
“Using Amalga and HealthVault, we will be able to connect all of the stakeholders involved in REMS programs and make it much easier for them to get the right information at the right time to help improve patient safety. We look forward to seeing the positive impact our solution brings to PPD clients as they manage the prescription drug life cycle.”
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