Accelerating Clinical Data Review With Traceable Workflows

Clinical trials are increasingly complex, generating vast amounts of diverse data, from genomic to real-world sources. However, traditional tools, like static spreadsheets and siloed systems, create paper trails, slow decision-making, and introduce compliance risks. Effective management requires technology-driven solutions that provide real-time data access and traceable workflows.

Centralizing all clinical data in one hub solves fragmentation issues, ensuring harmonized and up-to-date information for real-time analysis across all trial sites. Automation of the entire data pipeline, including machine-learning-based mapping from EDC to SDTM, eliminates bottlenecks like manual exports and batch transformations. Further, all data interactions, annotations, and queries are logged comprehensively, generating a real-time, regulatory-ready audit trail that documents who made decisions, why, and when, mitigating compliance risks. This centralized, collaborative environment allows all stakeholders—from data managers to safety officers—to work with a single truth, accelerating query resolution and providing critical velocity to studies.

Download the application note below to find out how to reengineer your clinical data review for faster, better-informed decisions and clearer oversight.