- Feasibility assessment of protocols
- Writing protocols, patient information and consent forms
- CRF design
- Translation of research related material for the relevant national regulatory institutions and for the potential patients
- Trial permission/approval from the National Drug Agency and the National
Ethics Committee
- Consultations on local variations of GCP and other regulatory documents
- Organising of investigator meetings
- Experienced investigator identification, selection of investigators according to criteria defined by SMP and/or the Sponsor
- We can offer investigators or freelance monitors
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- Site identification, evaluation, selection and initiation
- Negotiating the right hospital agreements
- Project management
- Drug import and distribution
- Monitoring and organising bioequivalence studies and clinical trials phase II - IV
- Standard operating procedures designed to fully meet international
guidelines on clinical trials and are adapted to Romanian conditions
- Audit and Quality Control of investigator centers during the clinical studies
- Close-out visits and final reports (Clinical Study Report)
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