Institutions and Co-Creation of Value in the Service Ecosystem of Clinical Trials for the Development of New Medicines

Abstract

The pharmaceutical sector has outsourced R&D value chain activities, leading to the emergence of a new population of companies called clinical-trial Contract Research Organisations (CRO), focused on offering clinical-trial services to pharmaceuticals. They grew and quickly set up themselves as multinationals, proving global ecosystems of clinical-trial service. This chapter analyses in an exploratory way the relationship between regulatory institutions for clinical trials, national culture practices, and the cocreation of experience and value in clinical trial ecosystems in Brazil. The research was based on an inductive approach. We characterised the formal regulatory institutions, cultural practices and conducted in-depth interviews with coordinators of clinical trials in 8 CROs in Brazil, collecting primary data on their experience. Data were analysed using categorical thematic analysis. The result shows that national cultural practices and regulation influence the experience and value co-creation in the provision of the CROs' clinical trial service.