Organization of clinical trials and observational innovative drug treatments as well as medicinal products within the following scope:
- Management of clinical research projects
- Clinical monitoring
- Submission of clinical trials to Bioethics Committees and the Central Register of Clinical Trials;
- Oversight visits;
- CRA training visits;
- Quality visits
- Feasibility process;
- Preparation of a study site for audits and inspections;
- GCP training;
- e-CRF with mobile applications for study participants (e-diary; e-PRO) – under construction
- Preparation of complete documentation for clinical trials (Study Protocol, Investigator’s Brochure, Study Final Report, questionnaires for patients, Informed Consent Forms)