The legal consultants in the network negotiate across all five Danish healthcare regions. The legal consultants are in close contact with the hospitals and sites where clinical trials take place.
The main task of the network is to ensure smooth and efficient negotiation of contracts in connection with the implementation of clinical trials in Denmark. Companies and/or CRO’s may negotiate company/CRO specific templates or use the Danish Regions’ standard templates.
In respect of time, there are major benefits associated with the use of templates as the network strives to ensure that these are approved as quickly as possible. Company/CRO specific templates will of course take time to negotiate – however, once these are agreed upon the legal approval of the specific templates will be 3 working days. If there is no time for negotiation of specific templates, the Danish Regions’ standard templates can be used.
The network's tasks include:
- Negotiating national contracts with companies
- Preparing and maintaining templates including Danish Regions’ standard templates and company/CRO specific templates.
- Continuously considering the need to establish new and different types of templates in addition to the existing contracts.
- Working to attract clinical trials to Denmark, including entering into dialogue with the authorities and the industry with regard to legislation, etc. which may be a barrier.
- Serving the industry as a customer in connection with the implementation of clinical trials.
- Serving the regions'/universities' researchers in connection with the implementation of clinical trials conducted on behalf of industry.
- Cooperating with the clinical consultants.
• Contact information - the legal consultants