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.