Clinical Trial Services
In case of phase I-IV. clinical trials, trials conducted with medical devices, non-interventional studies, registry studies, post authorization safety studies (PASS), post authorization efficacy studies(PAES) and medical research studies we offer our sponsors the following services:
1. Medical writing (protocol, patient informed consent, monitoring plan, CRF, clinical study report, etc.)
2. Regulatory: submission of clinical trials for authorization, elaboration of documents for submission to local authorities and ethics committees.
3. Organization and conducting of clinical trials
- Selection of clinical study sites
- Feasibility studies
- Contract management
- Organization of investigators' meetings
- Opening and initiation of study sites
- Remote monitoring
- Risk based monitoring
- Regular monitoring of study sites
- Closing of study sites
- Representation of the sponsor
- Keeping contact with the local authorities
4. Translation of documents used in clinical studies
5. With our partners' cooperation:
- Data Management
- eCRF hosting
- Statistics
- Medical Monitoring
- Pharmacovigilance
- IB, IMPD, CTD modules, RMP writing
If you have any questions please do not hesitate to contact our colleagues or ask for our references.