FEASIBILITY
- Selection of Investigators and Clinics
- Development of questionnaires and surveys
- Analysis and evaluation of project feasibility in the country
PHARMACOVIGILANCE
- Preparation, submission of safety reports to regulatory authorities
LOGISTICS SUPPORT
- Logistics support (import/export, study consumables)
- Organization of storage of IMP and study materials
- Selection of local vendors and control of their operation
REGULATORY
- Adaptation of documents according to local requirements
- Development of study documentation in accordance with local laws
- We obtain the approval of the MOH of Ukraine and LEC
- Concluding agreements with clinics and investigators, making payments
- Consultations on local legislation in the field of medicine and pharmacy
MONITORING
- Conducting of SSV, SIV, MV, COV. On-site or remote visits
- Trainings for investigators and medical staff
- Technical support for equipment operation during the study
