PPD, Microsoft team up for REMS management

Adding to Microsoft's growing presence in the clinical trial business, contract researcher PPD says it's working with the software giant on a solution for managing REMS programs. The partners have agreed on a joint implementation based on Microsoft's data aggregation platform--the Amalga Unified Intelligence System--and HealthVault, a personal health application platform.

The concept involves a platform that connects all of the stakeholders involved in Risk Evaluation and Mitigation Strategy programs, which appear to be gaining traction with the FDA as a condition of drug approvals. The programs are driving collaborations not just among stakeholders, but also among units within stakeholder companies.

"Given the nature of REMS programs, multiple departments that traditionally worked together only in a peripheral way or during transitions are now jointly supporting products throughout their lifecycle," says Frank Gallo, executive director for risk management at PPD, in our collection of expert tips for REMS success. "Each department responsible for executing specific components of the program should be involved from the beginning of the process." 

The partners are planning a system that will help users manage the operational components of REMS programs. It will incorporate elements to help users connect and manage program components while simultaneously tracking information from such sources as patients, healthcare providers and pharmacies.

There's no word yet on availability.

- see the PPD release