Insife awarded contract to deliver state-of-the-art vigilance technology platform for the MHRA

Insife has been awarded a contract for the delivery of a new state-of-the-art vigilance technology for the Medicines and Healthcare products Regulatory Agency (MHRA), which will help transform how the MHRA manages patient safety for all regulated healthcare products and establish a more responsive surveillance system. “We were looking for a product that could support our ambitions to deliver an enhanced and more responsive safety surveillance system for all healthcare products,” explains John Quinn, interim Executive Director and CTO at MHRA. “We tendered for a partner with experience and expertise on innovative technologies in this field to strengthen our vigilance capability.”

This new technology will support the MHRA to transform how it manages safety monitoring through joined-up reporting, data capture and provision of information and ultimately ensuring patient safety. Insife’s HALO solution, which will be implemented to perform case management and operational reporting activities, leverages advanced automation such as artificial intelligence to ensure more accurate multivigilance analysis and processing. Insife CEO, Martin Holm-Petersen, comments “The MHRA is moving towards new ways of working and thinking, using HALO as an advanced technology to augment information processing and surveillance, on behalf of patients. At Insife, we are determined to make this transformation a success and are of course proud of being awarded this contract by the MHRA.”

Insife will partner with Commonwealth Informatics, a Genpact Company, to implement the Commonwealth Vigilance Workbench (CVW) platform which is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources.

Once implemented, the new solution will serve as the hub that processes multiple sources of adverse incident data. The programme implementation kicked off in June and is planned to run through to the second quarter 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.

MHRA, based in London, is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for regulating medicines, medical devices and blood components for transfusion.

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.

About Insife

Founded in 2017, Insife offers specialist consulting services in pharmacovigilance (PV), regulatory affairs (RA), technology and IT, delivering innovative solutions and insights to pharma and life sciences companies in Europe, North America and Asia.

Insife services are based on expertise across the pharma value chain with an understanding of the potential for digital transformation in the life sciences industry and drug safety assurance through process optimization and automation.

Insife provides a portfolio of proven and scalable end-to-end (E2E) business process, organization and technology solutions that have been applied across a spectrum of clients ranging from medium and small size businesses to the Pharma Top 25.

These offerings include E2E Drug Safety Consulting and Technology services, the proprietary HALOPV global safety database, AI Data Analyzer tool that applies AI technology to unstructured data sets, and Insife.cloud, an innovative cloud-based IT platform that provides a total one-stop-shop for pharmacovigilance drug safety and GxP compliance.

Over its first three years of operations, Insife has been growing revenues at an average rate of 300% annually, and now has additional offices in the US, India, Germany and the UK.