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