Non-Interventional Studies (NIS), Post Authorisation Safety Studies (PASS) and Post Marketing Observational Studies (PMOS)

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

The quality of planning and conducting of a 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.

Study preparation:

  • 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

Study controlling and evaluation:

  • 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 of our professionals