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Experts' meetings
• Identification of (clinical) experts, preparation, organisation, and delivery of meetings • Identification of experts (from regulatory authorities); preparation, organisation and delivery of meetings.
Feasibility studies
• Identification of opinion leaders • Identification of investigators and centres • Evaluation of costs • Evaluation of time scales
Development plan
• Clinical development plan: advice and design services • Regulatory strategy: advice and design services.
Investigator brochure
• Design
Protocol
• Writting and design
CRF
• Design • Writing • Lay-out, production
Study documentation
• Design • Writing • Lay-out, production
Translations
Submission to authorities
• Preparation and submission of clinical reports to Ethics Committees • Preparation and submissions to medicines agency: applications for import licence • Preparation and submission of clinical project to the national commission for protection of liberties in IT Preparation and submission of dossier to the national association of doctors
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