We satisfy your needs!

 

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We conduct your clinical trial with your medical device through our offices in Germany (Karlsruhe), Switzerland (Basel), Austria (Vienna) and Poland (Krakow) or through our extended network of freelance clinical research professionals in all other European countries

 

 

according to

  • the EN 540
  • the Medical Device Directive
  • the applicable laws and other regulations

We

  • help you with your project set up and planning
  • notify the competent authority and submit to local ethics committees
  • help you to obtain the CE - mark from the notified body
  • report adverse incidents to the Ministry of Health
  • monitor your trial
  • help with Data - Management
  • write study reports, protocols and help to design your Case Report Forms
  • audit your trial

Please do not hesitate to contact us for further information:

info@clinicalresearch.de

 

 

Joern Gatermann, MSc,
Certified CRA
Clinical Research
Consulting

Pfarrer-Graebener-Str.
1a
D - 76149 Karlsruhe
Germany

Phone:
+49 (0) 721 - 7569308

Fax:
+49 (0) 721 - 7569309

Mobile:
+49 (0) 170 - 4845130