Mån 17 jun / År 42 / Nr 1 2024

LINK Medical: People and plans working together

LINK Medical is a full service CRO with offices in Norway, Sweden, Denmark and Germany. Founded by CEO Dr. Ola Gudmundsen in 1995, LINK Medical provides project management and product development services for the pharmaceutical and medical device industry

Companies, particularly small and medium enterprises, can find it hard to provide all of the expertise needed to develop a drug from in house, and this is where they turn to contract resource organisations (CROs), such as Link Medical, for help.
“We see ourselves as one of the few full-service CROs that can provide preclinical studies and clinical development support for small and medium companies [SMEs], which can struggle in the transition between preclinical and clinical development. LINK Medical is the ‘right size’ for these companies, who simply cannot afford the use of the very large global CROs but find that small CROs cannot offer a full service,” says Ola Gudmundsen, the Norway-based CEO and founder. “We are not just a preclinical or clinical CRO – we can support companies through the translation.

Bringing in a translational approach
LINK Medical provides the full spectrum of services, from preclinical development through to regulatory services, and brings a cost-effective translational approach to product development, explained managing director Jan Hellqvist, who is based in Sweden: “We bring a local approach. From our bases in the Nordic countries and Germany, we remain closer to our clients, but we can carry out studies throughout the world with our global network of CROs and consultants. We also pride ourselves on being able to provide value because of our expertise from years of experience across a breadth of services.”
Link Medical covers a variety of therapeutic areas, including cardiology, immunology, and vaccines, but its key therapeutic focus is oncology. The company has supported over 50 clinical trials in oncology over the past three years, and has been a member of the Oslo Cancer Cluster in Norway. since 2011

Crunching the numbers for SME biopharma
Statistics and data management can be challenging for smaller companies, particularly as the quantities of data produced during development and after launch is increasing. The company provides expertise in statistical planning, analysis and reporting, as well as services for data management in clinical trials.

Managing medical devices
The global medical devices industry is growing, driven by increasing innovation and the demand from a growing population. LINK Medical has created a dedicated business unit specifically to support SMEs developing medical devices, particularly during the changes currently taking place in EU medical devices regulation.
“We work from the idea to the market, looking at the development and marketing strategy. WE can provide support throughout the process, for example looking at CE marking and classification, evaluating the health economics, planning clinical trials, interacting with Notified Bodies, and putting in place quality systems,” said Hellqvist.

The future for LINK Medical
Link Medical’s revenues grew by 30% in 2016, and its employee numbers grew by 36%, with the company reaching 100 employees in 2017.
“We cover the Nordic regions and Germany, and we have a vision to become a fully European CRO,” said Gudmundsen.