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Information |
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Establishing, Medical Writing
Medical Writing of
- Protocol
- CRF
- Patient Informed Consent
- Patient diaries
- Submission documents
Selection of Investigators/Sites
- Site selection
- Pre-Study visits
- Feasibility
- Setting up of sites
- Logistics
Regulatory Affairs and Ethical Procedures
- Application for CA approval and EC opinion/response
- Updating service during ongoing projects
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