Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe.

•The EHR4CR technological platform can enhance and speed up clinical research.•A business model is needed for reusing electronic health records data for research.•A multi-stakeholder value chain and adapted value propositions are key enablers.•Clinical study conduct is lengthy and laborious, and the reporting of serious side effects is poor.•Robust simulation modelling is useful to strategic planning and business decisions.