Trial Nation templates – a shortcut to shorter contract negotiations
If you are going to conduct clinical trials with a company, then Trial Nation templates are a quick way to get the contract in place. The aim of the contract templates is to streamline negotiations and ensure the fastest possible processing time, as they are pre-approved in all Danish regions.
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Who is Trial Nation?
Trial Nation is an association aiming to promote and facilitate clinical trials in Denmark. The association serves as a national entry point for pharmaceutical companies, among others, which are looking to sponsor, participate in and/or conduct clinical trials in Denmark.
The association includes members from the Danish regions, who have set up a legal network to remove legal barriers through the preparation of national templates, thereby making it easier and more attractive for the industry to conduct clinical trials in Denmark. This is ensured by the regions having a common starting point for cooperation with industry, with common contract templates.
Trial Nation has prepared templates for use in clinical trials and it also negotiates company-specific templates with pharmaceutical and medical device companies, etc.
The templates are increasingly being used and help ensure that company-initiated clinical trials can be implemented more quickly in Denmark.
What’s in it for me?
As mentioned previously, the contract templates have been pre-approved in all regions – and if they are used without changes, they can be approved by the TTO within three-five business days.
Trial Nation has prepared templates for the following purposes:
- Non-disclosure agreement for sharing the company's protocols,
- Agreement on conducting clinical trials with the company's medicinal product, and
- Agreement on clinical testing of the company's medical devices.
In addition to Trial Nation's own templates, Trial Nation has agreed contract templates with a number of Danish and foreign companies.
Get off to a good start
The templates are freely available on the Trial Nation website and can be downloaded and used as they are. Simply fill in the relevant boxes using track changes and then send the agreement for administrative approval at TTO.
Talk with the company you are going to work with about using the Trial Nation templates for a smoother process.