Implementing the Georgian regulatory framework for a multinational clinical trial programme
Healthcare · Clinical research · Data protection
Montpellier Sentinel Legal supported a multinational organization in assessing and implementing the Georgian regulatory framework applicable to clinical trial activities, including post-marketing and Phase IV activities.
Our work covered the local legal framework governing clinical research, patient and participant documentation, informed-consent considerations, processing of health and other sensitive personal data, privacy requirements, data transfers and contractual relationships among the relevant parties involved in the trial.
The engagement required the alignment of the multinational organization's global clinical and privacy standards with Georgian regulatory requirements and the practical processes required for implementation in the local market.