Legal Alliance possesses an extensive experience in legal counseling of pharmaceutical market actors regarding clinical trials support at different phases and at postmarketing research stage.
Our associates constantly face the legal issues of conducting clinical trials. They develop clinical trials funding models, draft the agreements with clinical trials providers, clinical bases, researchers, and insurance companies.
Legal Alliance team extends legal clinical trials support in Ukraine to such pharmaceutical companies as Boehringer Ingelheim, Bayer and Servier.
1. Drafting of consent forms
2. Contractual relations legal support:
- Drafting of the agreements between sponsor and contract research organisation.
- Drafting of agreements between sponsor and healthcare organisation (site).
- Drafting of agreements with the participation of science and research institution.
- Drafting of agreements between the responsible researcher/ co-researcher and sponsor.
- Drafting of agreements to conduct clinical trials where contract research organisation is involved.
- Legal support of agreements conclusion with State Expert Center on the expertize of clinical trials materials / amendments expertize.
- Legal support of insurance agreements conclusion
- Participation in contract negotiations
3. Legal counseling regarding clinical trials:
- Regulation of clinical trials procedures
- Personal data protection within the framework of clinical trials
- Anti-corruption legislation
- Patients rights