Abstract 5517: Standardizing global patient safety and site compliance in oncology trials using a configurable, technology-driven oversight model.

Abstract Background: Variability in how adverse events (AE), protocol deviations (PD), and response assessments are reviewed across sites can delay detection of emerging issues in oncology trials—especially in global studies with dispersed teams. To address this, Premier Research implemented Remarque, a proprietary, technology-enabled data oversight platform to centralize trial intelligence, standardize review workflows, and provide near-real-time visibility into patient safety and data quality. Methods: Remarque integrates various clinical and operational data streams into a unified environment. Configurable analytics, dashboards, and built-in audit trails align clinical operations, data management, central monitoring, and medical/safety review on a single, traceable process. Key features include standardized review templates, data-driven alerts for AE clusters, customizable views of safety and efficacy data, and traceable documentation to support inspection readiness. Remarque was deployed across more than 30 oncology studies including novel therapeutics and first-in-class products, spanning different geographies. Results: Deployment of Remarque enabled earlier detection of common safety patterns, including clusters of low-grade toxicities and delayed AE entry. Studies using the platform achieved faster signal-to-action time and more consistent AE review. Near-real-time collaboration between central monitoring and medical monitoring allowed earlier flagging of potential eligibility concerns, decreasing eligibility-related non-compliance. Ability to trend data patterns within and across sites allowed for monitoring of site's execution of critical processes such as AE capture, reducing time to detection of AE underreporting from an average of 4-6 weeks down to 5-7 days. Notably, Remarque central monitoring identified 55% of PDs that occurred, with a 20% reduction in time from PD occurrence to identification. Centralized traceability strengthened data defensibility for regulatory review and facilitated proactive remediation of recurring data-quality findings. Overall, this resulted in cleaner data, efficient patient safety management, and improved patient retention. Conclusions: A technology-driven oversight model improved the reliability, transparency, and timeliness of data review in oncology trials. By replacing fragmented processes with a standardized framework, Remarque enabled earlier signal detection, reduced variability, and improved data quality. This approach reflects how integrated digital infrastructure enhances clinical and medical oversight and supports the goal of safeguarding patients while accelerating efficient delivery of effective cancer therapies globally. Citation Format: Ashley Herrick, Dmitri Berman, Elaina Haeuber, Sandy Shah, Salini Naidu, . Standardizing global patient safety and site compliance in oncology trials using a configurable, technology-driven oversight model [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 5517.