STARS will establish, regularly update and disseminate a Comprehensive Inventory of existing support activities for regulatory Scientific Advice and Protocol Assistance in Europe. Up to know, this information has never been compiled in a single place.
Surveys are planned to obtain the required information. The surveys will target:
- academic clinical researcher, groups and projects as well as
- funding organisations active on national and European level and
- EU national coordination points (EU-NCP).
The intention is to also identify best practices suitable to be implemented in other countries within the European Economic Area. This could harmonise and strengthen their impact on innovative programmes for timely delivery of the drug innovations for the benefit of patients.
A further objective is to identify the needs and gaps in regulatory guidance for the academic health research.