The K&P team provides legal advice to entities involved in clinical trials, in all phases of such trials. We provide emergency/crisis advice, in particular risk identification and explanation of the principles of liability of the CRO, investigator, site, sponsor.
We provide the following services:
- Drafting, reviewing drafts of and negotiating agreements related to the conduct and supervision of clinical trials, including clinical trial agreements (between the sponsor, CRO, and agreements with investigators), insurance agreements and clinical trial financing agreements
- Advice in connection with proceedings before the Chairman of the Office for Registration of Medicinal Products and the Central Register of Clinical Trials
- Opinions on legal issues arising in the course of clinical trials, in particular with respect to regulation of clinical trials, the rights of clinical trial subjects, as well as in connection with the occurrence of adverse events and effects, liability for damages and inspections of clinical trials
- Advice on the application of the rules for the protection of personal data processed in connection with clinical trials
- Advice on compliance of medical records