Non-interventional studies (NIS and PASS)
R&P offers a full NIS service. This can cover conception, planning and implementation of all or parts of the study. This can of course also be on-line or in pharmacies.
In more detail, our service includes:
- Pro- and retrospective cohort studies
- Post-authorisation safety studies (PASS)
- Case control studies
- Observational studies
- Planning of the concept and discussion with experts
- Acquisition and involvement of opinion leaders
- Creation of the observational plan, creation of observation form and all materials (paper and online documentation)
- Quality assurance, plausibility check, AE and SAE management
- Data management
- Completion of payment
- On-site audits
- Statistical evaluation
- Biometric and/or integrated final report
- Publication and public relations
- Monitoring/auditing with and without AD