Business Insights

MHRA Expands Relationship with Commonwealth Informatics to Transform Drug Safety

Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom.

MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Commonwealth Vigilance Workbench (CVW), to support the MHRA transformation of safety monitoring through a single integrated platform across all medicines, vaccines, blood components and devices.
"The MHRA is looking to transform our vigilance services through new ways of working, underpinned by the technology we use and how we operate our services. We see our partnership with CVW enabling us to deliver a more responsive safety surveillance system through innovative technology."
 Mick Foy, Head of Pharmacovigilance Strategy at MHRA

"We are delighted to have the opportunity to build on our longstanding research collaboration with the MHRA and deliver future value through greater efficiencies within signal detection," said Bill Blackwell, Commonwealth VP Safety Science Solutions. "The collaborative partnership will enable us, together with the MHRA, to bring new innovative methodologies to safety surveillance on behalf of patients."

Commonwealth's solution will be implemented to perform signal detection and signal management across multiple data sources leveraging advanced automation, such as artificial intelligence, to ensure more accurate multivigilance analysis and processing.  CVW is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources.

The MHRA is deploying Insife's HALOPV solution for case processing management, advanced automation, and real-time reporting and analytics. Commonwealth Informatics has partnered with Insife, to integrate CVW with HALOPV and to collaboratively deploy the end-to-end multi-vigilance platform in Q2 2022. Insife, headquartered in Denmark, offers specialist consulting services in multivigilance (Medicines and Devices), Regulatory Affairs (RA), and Information Technology (IT) implementation. Insife's services are based on expertise across the life sciences value chain with an understanding of digital transformation and drug safety assurance through process optimisation and automation.

About Commonwealth Informatics
Commonwealth Informatics is a technology and services company with industry expertise in medical product safety and public health surveillance. Pharmaceutical and biotechnology companies, government agencies, and healthcare providers use Commonwealth's products and services to assemble relevant data and answer complex clinical and safety analysis questions quickly and accurately. Commonwealth is an independently-operated subsidiary of Genpact, a global professional services firm focused on delivering digital transformation. 

About Medicines and Healthcare products Regulatory Agency
MHRA, based in London, is an executive agency sponsored by the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusion in the United Kingdom. Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

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