Pharmacovigilance Systems and Processes Standards

Challenge

The pharmacovigilance (PV) software solutions lack interoperability, making it difficult for Marketing Authorization Holders (MAHs) to adopt best-of-breed solutions. Although PV system requirements are broadly similar across organizations, each MAH independently defines specifications for procurement and implementation, driving up costs and complexity for both buyers and vendors. Existing solutions rarely cover the full spectrum of PV needs comprehensively, and the absence of integration standards leads to widespread customization. As a result, innovation and automation are stifled by the significant effort required to establish foundational capabilities and ensure compatibility with legacy systems.

Solution

The PS² – Case Intake project aims at establishing common Case Intake solution requirements and interoperability standards and a corresponding logical data model and data dictionary. In addition, the project will establish an operational approach to sustain those standards and certify software solutions against them. This will be achieved by working with MAHs as well as suppliers.

Benefits

For sponsors:

• Lower costs: Standard requirements re-used across sponsor companies, less customizations
• Easier and faster solution evaluation via certification process
• More innovation: Ability to integrate best-in-class solutions, PV resources focused on innovation, vendors incentivized to differentiate through innovation

For suppliers:

• Lower costs: Answers to RFPs for standard requirements can be re-used, no need to elicit standard requirements
• Higher requirements maturity: Standard requirements will have been vetted across sponsors and are less variable