Advising clients in connection with the categorization of clinical studies. Assistance in connection with obtaining the necessary licenses and approvals. Drafting, localizing and negotiating agreements to be concluded with the sites, principal investigator, investigators, and other stuff members and services providers (e.g. laboratories). Preparing, localizing, translating other study related documents (e.g. patient information leaflet, informed consent form, etc.).
Ensuring compliance with the data protection laws and regulations throughout the study. Assisting clients in connection with liability related matters related to studies.
Advising and representing clients in connection with the resolution of claims arising from clinical trials. Drafting and negotiating settlement agreements, representing clients before the court.