Building Clinical Trials Capacity in a Developing Research Ecosystem

The successful establishment of a Clinical Trials Unit (CTU) in March 2024 presents a case study in building clinical research infrastructure within a growing academic medical ecosystem. This report outlines the first-year achievements of the CTU, details operational and regulatory challenges, and documents the strategies used to drive progress. Through strategic partnerships, capacity building, and external benchmarking, the CTU laid the foundation to emerge as a credible site for industry-sponsored and investigator-initiated trials. From inception, high-level university governance supported the unit, providing institutional legitimacy and strategic alignment. Support from the Saudi National Institute of Health (SNIH) facilitated early access to training and multi-institutional collaboration platforms. This case study relies on internal records, regulatory timelines, Standard Operating Procedures (SOPs), and training documents. The model shared may guide similar capacity-building efforts in academic institutions within developing research ecosystems.