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Clinical Studies in accordance with GCP
If clinical studies or case series have to be carried out, you will find us to be a competent partner. From the definition of study objectives to the final presentation of study results in your company, we are there to support you and to look after procedures for handling the study.
Our individual services include
- Drawing up the study design and study protocol
- Obtaining the necessary decisions from ethics committees, submitting applications for approval of studies by the German Federal Institute for Drugs and Medical Devices (BfArM)
- Recruiting investigators
- Performing external quality assurance of clinical studies according to GCP guidelines
- Statistical analysis
- Final report: presentation of the study results in your company
- Publishable manuscript (- if requested)
- Information to investigators on study results
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Clinical Expert Reports
