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Who we are
Medical Devices
Drugs
Contact Form
Jobs
Contract Hire
Impressum
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Medical Devices
 Links
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
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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
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