We satisfy your needs!

 

Who we are

Medical Devices

Drugs

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

 

 

according to

  • DIN EN ISO 14155-1 and DIN EN ISO 14155-2
  • the Ordinance on clinical trials of therapeutic products (VKlin/Oclin)
  • the Federal Law on medicinal products and medical devices (HMG)
  • 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.ch

 

 

Joern Gatermann, MSc,
Certified CRA
Clinical Research
Consulting

Baarerstrasse 73
CH - 6300 Zug
Switzerland

Phone:
+41 (0) 41 500 0396

Fax:
+41 (0) 41 500 0397