Clinical studies

CRO Case Studies

CRO Case Studies

At LINK Medical, our offering of in-house expertise, modern technology and active client communication is changing the industry’s expectations of a CRO partner. The strategic partnerships we form with our clients have accelerated the development of a range of diverse products. To find out how our services can add value to your business, contact us.

Gedea Biotech TPP workshop

The Challenge: Gedea Biotech needed support in developing and improving the strategy for their product entering the market.

The Solution: We organized a whole-day TPP workshop where we had an intense day of brainstorming and discussions with all of the Gedea Biotech team members, hosted by a group of our senior medical, clinical, regulatory and early development experts.

The outcome of the workshop was a substantially improved understanding of how to best differentiate Gedea Biotech’s product, as well as a defined strategy and desired outcome for the clinical trials they were about to initiate. Gedea Biotech saw the workshop as a very valuable step forward in their product development.

Annette Säfholm, CEO Gedea Biotech, said “The TPP workshop provided by LINK Medical substantially improved our strategy and made the planning of clinical trials much easier.

Exploring market access of a medical device with health economic modelling

The purpose of this project was to assist Mentis Cura, a digital diagnostic company, in the reimbursement process of their medical device used in dementia diagnostics, Sigla™. Our service involved developing a health economic model for Norway, Sweden, Denmark, and Finland.

As with most medical devices, the quality and quantity of effect data are greatly limited. Therefore, the Norwegian authorities decided not to assess the effect of implementing Sigla on a national level. This led to the conclusion that the best approach for getting Sigla to the market was by directly approaching hospitals and other institutions that assessed patients suspected of dementia.

We developed a flexible model to be used in price negotiations, followed by a market report, and a technical report explaining the model. The model proved to be an extremely useful tool, enabling Mentis Cura to explore the monetary effect of implementing Sigla in multiple scenarios.

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