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Poradenství
- Strategie generování klinického důkazu
- Design PMCF studií
- Design klinických zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
- Klinické hodnocení (plán/zpráva)
- Post-Market Clinical Follow-Up (plán/zpráva)
- Post-market surveillance (plán/zpráva)
- Periodic Safety Update Report (PSUR)
- Literární rešerše - součást dokumentace i samostatně
- Biologické hodnocení
- Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
- Klinický expert relevantní pro daný lékařský obor
- Specialista na management rizika
- Zpracování ostatních částí technické dokumentace
