NIS
Experience of conducting NIS studies with more than 30,000 patients in total.
General:
- Checking the feasibility of the planned NIS project
- Placing the NIS at the investigator's site
- Conducting the NIS according to the BfArM, VfA and GEP requirements
- NIS Design - Selecting the appropriate design according to the aim of the project, pharmacoeconomic study planning and conduct: Cost/benefit analysis, Quality of Life.
In Detail:
- Development of the NIS observational plan/documentation form: layout, content and internal consistency
- Logistics:
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- Registration of contracts and backflow of documentation forms - Contacts with investigators - Status reports - Close contact with responsible person at sponsor's site, e.g. sales force - Quality assurance - Payment management |