Non-Interventional Studies

All-round service until successful completion

We will help you to meet the permanently growing amount of European and international requirements (e.g. as a result of regulatory amendments, etc.) for the conduct of a Non-Interventional Study (NIS), Post Authorisation Safety Study (NIS-PASS) or a Post Marketing Observational Study (PMOS).

The quality of planning and conducting of a NIS / NIS-PASS / PMOS determines the reliability of your results. Only highest quality standards guarantee optimal results.

You will receive a complete service package from concept development and submission to authorities over layout, printing, distribution of study documents to remuneration management and publications.
  • Planning and design of observation plan
  • Development and design of informed consent form
  • Biometric consulting
  • Design of Case Report Forms (CRFs – paper or EDC)
  • Administrative/logistical preparation and handling
  • Management of contractual agreements
  • Submission to Ethics Committee and Competent Authority
  • Site selection and feasibility check
  • Cooperation with sales representatives of the sponsor, as well as training
  • Organisation of investigator meetings
  • Quality assurance
  • Support of the sites
  • Monitoring
  • Check of completeness and plausibility
  • Support of investigators at site
  • Key contact person between sponsor and investigator
  • Remuneration management
  • Documentation / Reporting of AEs and SAEs
  • Status reports
  • Data management
  • Biometrical evaluation of data
  • Coding (MedDRA, ATC, WHO, etc.)
  • Preparation of study report, presentation of data
  • Compilation of a manuscript for publication
  • Insourcing / Support by our professionals