In clinical studies, we differentiate between clinical trials according to the German Medicines Act, the EU Medical Devices Regulation (MDR, 2017/745) and trials that do not fall under either of these laws.
Clinical studies are necessary if existing data cannot prove the safety, efficacy, benefit, or risk-benefit ratio. This is the rule for new products.
Based on our experience, we can therefore advise not only on the conception, applicable regulations, and planning of clinical trials, but also on the implementation of the individual aspects in practical implementation.
Depending on your wishes, our operative services include:
- Preparation, control IMPD
- Study concept and study design
- Contact to decision makers and international specialists
- Inspection plans
- Case number estimation and advice on biometric design
- Budget calculation
- Regulatory management
- Contact and communication with authorities (BfArM, DIMDI, Ethics Commission, PEI, G-BA)
- Ethics proposals
- Development and validation of questionnaires
- Biometric statistics
- Selection and recruitment of study centres
- Project management
- Site management
- Monitoring / quality control and assurance
- SAE management
- Patient / volunteer recruitment
- Security management
- Online documentation of patient and volunteer data
- Leading investigator function
- Study documentation
- Creation / control of statistical analysis plans
- Data management
- Complex scientific-medical writing
- Clinical trial report
- Preparation of expert opinions by AWB for the medical aids register of the GKV-Spitzenverband
With which services can we support you? Please feel free to contact us.