Clinical Research

MIT Gesundheit - Clinical Research

If a clinical study or application monitoring (AWB) has to be carried out – clinical research – you will find a competent partner in us.

Clinical Research – Clinical Trial GCP-compliant

From the definition of the study objectives to the final presentation of the study results in your company, we will be at your side and take care of the management of the study.

Our individual services include

  • Preparation of the study design and protocol
  • Obtaining the necessary ethics votes, applying for study approval from the BfArM (German Federal Institute for Drugs and Medical Devices)
  • Recruitment of investigators
  • Performing external quality assurance of clinical trials in accordance with GCP guidelines
  • Statistical evaluation including subject-specific expertise
  • Final report: presentation of the study results in your company
  • Manuscript ready for publication (if requested)
  • Information of the investigators about study results

Pharmacovigilance – Further Services

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