NIS
Experience in the implementation of NIS
with more than 50,000 patients in total.
Whether as a full service or only for specific services, PHARMALOG has extensive experience in conducting non-interventional studies (NIS). Even large amounts of data can be entered and evaluated quickly thanks to short routes and internal data management. We create the appropriate study design in accordance with your project requirements.
We provide support for all types of NIS
- Case series
- Cohort studies
- Registry studies
- PASS
- PAES
- Pharmacoeconomic studies
Services
- NIS Design - Selecting a suitable design in accordance with the project’s objectives
- Checking the feasibility of the planned NIS
- Developing the monitoring plan/documentation forms
- Implementing the NIS according to BfArM, VfA and Good Epidemiologic Practice (GEP) guidelines
- Logistics
- Contract design with sites and invoice processing
- Status reports & monitoring data input
- Close contact with the Sponsor’s person responsible for the project, e.g. sales
- Quality assurance
