Independent Clinical Research Associate / GCP audit assistant in Ukraine. We are offering clinical monitoring, ICH GCP audits and other quality assurance consultancy services to biotech and pharmaceutical industry.
Clinical monitoring at Phase II/IV
- Feasibility studies and investigators selection
- All types of monitoring visits from qualification to close out
- CTA preparations / payments
Quality assurance and quality control
- Onsite and remote ICH GCP audits
- Quality oversight visits
- Consultancy
Regulatory
- Regulatory submissions to Ukrainian national competent authority
- Review and quality control of regulatory submissions
- Safety submissions
Other consultancy services to pharmaceutical and biotechnology industries
- Medial translations and localization
- ICF review and harmonization with local legislation
- Selection and management of 3rd party vendors