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Outdefine
Outdefine is a clinical trial decisioning system that helps clinical research teams accelerate site feasibility, monitor study risk, and improve trial decisions using governed data, trial-trained AI inference, and controlled workflow agents. It serves clinical trial sponsors, CROs, and life sciences organizations operating in regulated healthcare environments.
Distributed
Description
Outdefine builds a governed decisioning and execution layer that sits above existing clinical trial systems, connecting trial data, protocol rules, workflow agents, human actions, and outcomes so that every decision improves over time. Its platform supports feasibility and site selection by ranking sites based on patient fit, site performance, and enrollment risk, producing defensible shortlists for faster decisions. It also provides study health and risk monitoring by flagging site risk, enrollment lag, protocol deviations, missing data, and safety signals, and recommending owners and next-best actions. Additionally, Outdefine supports real-world evidence and synthetic cohort analysis by identifying cohorts, eligibility gaps, and reusable evidence signals from patient footprint and real-world data. The company positions itself as built for regulated clinical and healthcare environments, citing SOC 2 Type II and HIPAA compliance, and serves clients across clinical trial operations, life sciences, and healthcare systems seeking faster, data-driven, and auditable trial decisioning.Grant Funding
VC Funding
None
2022
$0
$5M