DIA 2021 Global Annual Meeting

Clinical trial complexity has dramatically increased over the past decade. Implementation of site- and customer-facing systems to adequately track sample chain of custody and drive data integrity have experienced numerous challenges, both in functionality and adoption. While the central lab industry has historically invested in testing platforms and internal lab information systems, they did little to solve the aforementioned issues plaguing clinical trials with regard to sample chain of custody, data integrity, and tools for sites or customers to use for real-time assessment. IT development of platforms in this space therefore require the ability to create a flexible architecture intimately linked to the lab information system and, more importantly, the need for continuous quality improvements with regular release schedules based on real user feedback for ease of use. PPD Laboratories designed the Preclarus central lab database to specifically address the common issues experienced, constructed with flexibility that can be adapted for multiple use cases. We will discuss the core functionality in the initial release and the subsequent flexibility upgrades, barriers to adoption, solutions and proposed future state that will fundamentally change the way central lab services are viewed and utilized in the industry.