Uppsala, Sweden June 7th 2021, - LINK Medical, a full-service contract research organization (CRO) providing product development and post-marketing services for the pharmaceutical and medical device industries, has signed a contract to join forces with Insife, an expert consulting and technology service provider for safety and pharmacovigilance organizations.
This partnership combines extensive experience and know-how from LINK Medical with a robust, enabling technology from Insife, providing LINK Medical with a top-of-the line safety database and other powerful supporting modules.
A fully-compliant safety database that also supports many of the critical pharmacovigilance processes
For the past four years Insife has developed the HaloPV platform that allows Safety/Pharmacovigilance organizations to automate many of their critical processes, freeing up focus to further support the patient journey.
The HaloPV platform provides a safety database and additional modules to support any Safety/Pharmacovigilance area in a fully compliant system. It goes beyond the regulatory requirements of a safety database, offering additional unique deliverables and in addition to that, it is very user-friendly.
The safety database can easily be set-up for clinical trials, allowing collection of safety data from all studies throughout the development phase, as well as throughout introduction of products to the market, where many additional regulatory requirements are introduced.
The HaloPV platform has gone through LINK Medicals rigorous vendor qualification process and is fully compliant with all the regulatory requirements. It constitutes much more than just a safety database, supporting many critical processes, e.g. literature monitoring, signal detection and management, managing the pharmacovigilance System Master File (PSMF) and agreements with vendors/partners and affiliates.
A winning collaboration for all
For Insife, the partnership contributes to building a network of partners and providing the technology to a wider range of customers in need of safety and pharmacovigilance tools.
“Part of our strategy is to cater to our micro clients. No client is too small to use our technology that large companies are using. Our partnership is a real door-opener, to deploy the same methodology from the smallest to the biggest companies. Our HaloPV platform is flexible, easy to use, and we can be a one-stop shop for the full pharmacovigilance deliverables of our clients”. Martin Holm-Petersen, CEO, Insife.
Through the partnership, LINK Medical can offer a safety database to all current and new clients with relevant needs. In addition, LINK Medical can offer more streamlined processes and services for our clients including such as Periodic Safety Update Reports, Signal Management and PSMF maintenance.
“Using Insife’s state-of-the-art technology makes sense for LINK Medical because it is in line with our mission to use top-of-the-line technology for our customers and fully compliant tools for managing our clients’ data. It also aligns with our vision to reshape safety and pharmacovigilance through process optimization and automation with an ongoing commitment for transparency and delivery excellence for all customers, and this can definitely be achieved with LINK Medicals safety and pharmacovigilance expertise”. Tina Elberling, Director International Safety Operations, LINK Medical.
Insife is dedicated to expert consulting and technology services for drug safety (pharmacovigilance, or PV) organizations. We are delivering innovative solutions and insights to pharma/biotech and agencies in Europe, North America and Asia. Insife is headquartered in Denmark, with additional offices in the US, UK, India, and Germany.
Our expertise includes a comprehensive understanding of the pharma value chain with a knowledge of how to apply digital transformation in the life sciences industry through process optimization and automation.
Insife’s end-to-end global safety database, HaloPV, is a game-changing pharmacovigilance platform that provides organizations with the efficiency and automation needed for state-of-the-art PV process management. With this platform, drug safety organizations can manage and automate PV processes. These capabilities have been applied across Insife’s client base, which ranges from pharma top 10 to medium and small size businesses. Insife strives to develop and implement forward thinking services and technology that empowers its customers and advances the safety of patients.
Vision and Mission
Insife was founded with a vision of becoming a global leader in life sciences by developing transformative solutions tailored to benefiting customers and their patients. Our mission is to re-shape drug safety through process optimization and automation with an ongoing commitment to transparency and delivery excellence for all customers.
For more information, contact:
Martin Holm-Petersen, CEO, Insife
About LINK Medical:
LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. We offer a well-integrated local presence in all Nordic countries, UK, and Germany. Reaching from early phase development to post-marketing, we have over 200 employees providing expert guidance across every aspect of a project – all from ONE source.
Our promise is to improve and accelerate your product development through transformative methods, active communication and optimal solutions. As a strategic partner, we provide expert competence and technology to enable evidence-based decision-making that support the delivery of superior clinical outcomes.