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Medical Science

Our experienced medical scientists are responsible for the conception, scientific supervision and data evaluation/reporting of national and international studies and have comprehensive knowledge in the regulatory fields of

  • Drug law / ICH-GCP,
  • Medical device law / ISO 14155,
  • Biomedical research according to the Medical Association professional code of conduct,
  • Non-interventional studies including PAS/PASS.

The following clinical trial services are provided by our medical-scientific team:

  • Study conception
  • Protocols / investigation plans for clinical trials and observational studies
  • Patient information materials and Informed Consent Forms
  • Review of study documents for medical-scientific conclusiveness and regulatory compliance
  • Medical review of study data
  • Final study report (ICH E3, EudraCT Summary, AMG §42b Synopsis, DIN EN ISO 14155 u. a.)
  • Preparation of scientific publications

Furthermore, our medical-scientific team offers the following services:

  • Technical translations English/German
  • Editing/Proofreading of medical and scientific texts
  • Preparation of presentations and training materials

Contact

Any questions, intestested in our services? Contact us!

Tel.: +49 7071 9992-0