ECRON provides all necessary regulatory and ethical procedures, such as
- application for an Ethics Committee opinion
- clinical trial application
- selection of coordinating investigator
- regulatory consultation of development programs
- assessment and evaluation of dossiers for regulatory submission
- preparation and compilation of regulatory submissions
- CHMP procedure
- national submissions
Accordance with ICH-GCP
ECRON assures for all countries accordance with ICH-GCP. By checking
and completing the local/national procedures and approvals (e.g. with bilingual
standard form for EC vote, translation of application and approvals etc.) the
ICH requirements are met and sponsors are provided with all documents requested
for filing and submissions.
National regulatory and ethical procedures
for clinical trials phases I-IV for
Angola
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
Denmark
Finland
France
Germany
Greece
Guinea-Bissau
Hungary
India
Indonesia
Ireland
Israel
Italy
Japan
Mexico
Mexico
Mozambique
Philippines
Poland
Portugal
Romania
Russia
Serbia
Slovakia
South Africa
South Korea
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
USA