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This research examines the impact of outsourcing on knowledge and technology development in clinical research, with a particular focus on early drug development. It explores how outsourcing, while offering short-term advantages such as cost reduction and access to specialized expertise, can lead to long-term disadvantages such as loss of knowledge, reduced scientific integrity and altered power dynamics between sponsors and vendors. The study highlights the ethical and philosophical implications of transferring responsibilities to vendors, including the potential for reduced autonomy and expertise among sponsor personnel and the risks associated with reliance on vendor-generated data. To address these challenges, an alternative operating model is proposed that emphasizes shared responsibility and greater involvement of sponsor staff in research activities to maintain knowledge integrity, ensure research quality and promote professional development.
