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