Clinical trials of medicines and medicinal products
The original medicine or medicinal product have come a long way at the moment of its launch. Our lawyers are part of making of this history. We stand by our clients’ side when setting documents for clinical trials made for the conditions of the local environment. We address the questions of the relationship between the sponsor, workplace and the trier. In accordance with global standards e share our opinion on the conditions for the protection of the research participants, method of processing their data and we handle the legal risks that are associated with the occurrence of adverse effects of the product investigated. We also participate in the negotiations with the regulator and we are part of teams working on modifications of the legislation to make it compatible with European standards.
We support our clients mainly in:
- consultation in the case of the content of documents related to the clinical trial, setting up the contractual cooperation and management of risks in relation to the sponsor-workplace-trier-participant of the trial,
- legal aspects and binding nature of GCP,
- protection of personal data of certain persons, protection of the results of clinical trial, protection of patients (ethical aspects),
- the resolution of legal issues relating to the relationship of public health and participation of the patient in the clinical trial (health care costs),
- tax aspects of the implementation of the clinical trial,
- legal representation in proceedings before the State Institute for Drug Control.