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