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Dictionary:

Satellite sites model – feasibility in clinical studies

The purpose of the development initiative is to investigate the feasibility of a model for satellite sites in clinical studies. The goal is to facilitate the use of satellite sites in the Swedish healthcare, academia and life science sector.

Background

The development investment immerse in some of the identified needs that the feasibility study "'Satellite sites' - make it possible to share study work between different healthcare authorities, clinics and units" "identified. Among other things, that there was a great interest and need for a satellite site model among most of the relevant stakeholders.

Implementation and goal

The development initiative will:

  • investigate the use of satellite sites abroad, both in the life science industry, healthcare and academia
  • explore how regulatory authorities view satellite sites in selected countries
  • follow a pilot study (clinical medicine trial) from application to implementation to document needs and content, which will then result in support documents / processes for a satellite model
  • disseminate produced material nationally through the regional nodes within the collaboration Clinical Studies Sweden and via the project's reference group.

Timeplan

The development initiative started in Q3 2021 and is expected to be completed in Q4 2022.