How Syneos Health Tackles Protocol Complexities

Syneos Health has effectively employed Medidata's Rave Electronic Data Capture (EDC) and Rave Randomization and Trial Supply Management (RTSM) solutions to optimize Phase IIV clinical trials, particularly under a complex adaptive trial protocol. This innovative approach allows for pre-planned modifications based on real-time data, enhancing trial flexibility and efficiency. The inherent challenges of adaptive design prompted Syneos to leverage programmatic codes within Rave EDC to seamlessly implement updates in Rave RTSM, facilitating adjustments in randomization and cohort management while ensuring system validation and minimizing downtime. The synergistic integration of Rave EDC and Rave RTSM not only streamlined data entry processes for site staff, eliminating the need for redundant data entry, but also mitigated data reconciliation issues associated with disparate systems. This cohesive framework significantly improved reporting capabilities and maintained data integrity. Ultimately, the collaboration between Syneos Health and Medidata enhanced the operational management of adaptive trials, showcasing the critical role of EDC and RTSM technologies in advancing clinical research efficiency.