Clinical Trials

We advise a large number of companies and institutions active in pharmaceuticals, medical devices and foodstuffs on the interpretation and application of EU and national legislation regarding clinical trials, including privacy implications, trial insurance requirements, adverse events and healthcare professional interaction. The degree of specialisation in this field, enables us to vector in upcoming changes in the regulatory framework and provide practical solutions to legal, commercial and scientific needs.

In addition, we draft and negotiate all agreements pertaining to clinical trials, both from an industry driven and investigator initiated perspective as well as with or for CROs. We furthermore represent insurance companies in disputes and settlements with trial subjects based on the Decree on Compulsory Insurance and clinical trial sponsors in product liability claims.

Finally, we know our ways in academia through in-house legal work at university medical centres and thoroughly understand the way in which IRBs evaluate clinical trial protocols. We can therefore efficiently represent our clients before such IRBs when changes to clinical trial protocols need to be approved or when investigators have views that diverge from those of the sponsor.