Services

Comprehensive counseling (in all topics mentioned below)
Organizing and conducting personalized and group trainings
Planning preclinical studies:
- In accordance with the applicable harmonized standards
- Or according to individual needs
Composition of clinical study documentation:
- Protocol (investigation plan) writing
- Compilation of investigator’s manual
- Data management planning
- Case report form (CRF / eCRF)
- Preparation of statistical analysis plan (SAP)
- Compilation of clinical study report
- Conducting a full regulatory authorization for a clinical trial
Compilation of technical documentation:
- Clinical evaluation (according to MDD / AIMD and MDR)
- Compilation of further elements of the technical documentation
CE marking
Coordination of post-marketing surveillance activities
- Compiling reports based on a market monitoring plan
Consulting on renewal of CE marking, all kinds of related services