Autonomous trial intelligence agents that work inside CRONOS — continuously reviewing data quality, monitoring sites, and generating QA evidence. Human expert oversight at every decision point.
As studies scale in complexity, site count, and data volume, CRAs, data managers, and QA teams face impossible workloads — detecting deviations, monitoring risks, and assembling audit evidence manually, under constant regulatory pressure.
Manual data review at scale cannot catch all protocol deviations in real time. Critical issues surface late — during audits, not during the study.
Risk-based monitoring requires continuous signal detection across dozens of sites. Manual processes create lags that allow issues to compound before intervention.
Assembling inspection-ready QA evidence from scattered study records is a manual, time-consuming process — often starting only when an audit is announced.
Aegis is not a standalone product — it is a native intelligence layer built into CRONOS, designed to continuously process trial data and surface actionable intelligence for qualified human review.
Continuously reviews study data against protocol definitions — detecting deviations, flagging data quality issues, and generating structured query drafts for Data Manager review. Works across EDC entries, lab data, and clinical events logged in CRONOS.
Monitors site performance metrics, subject enrollment patterns, and SDV completion status across all active sites — continuously generating risk signals and site performance intelligence for CRA and monitoring team review. Supports risk-based monitoring (RBM) frameworks.
Continuously structures and maintains QA evidence from CRONOS study records — organizing deviation records, CAPA evidence, and audit trail data into inspection-ready packages. Generates structured evidence drafts for QA Lead review and sponsor oversight.
Aegis operates as a native intelligence layer — continuously ingesting CRONOS study data, processing through specialized agents, and surfacing structured intelligence for human expert review before any action is taken.
Aegis agents are fully native within CRONOS — and are designed to operate with data from external eClinical systems for organizations with existing EDC, CTMS, or eTMF infrastructure.
Aegis agents operate against your specific study protocol — not generic AI pattern matching. Every deviation flag references the specific protocol clause it relates to.
No Aegis agent output is actioned automatically. Every insight, alert, and evidence package requires qualified expert review and approval before use in regulated study contexts.
Complete, timestamped records of what each agent reviewed, what signals were generated, who reviewed them, what was approved, and what actions were taken — accessible for inspection.
Each study's data is strictly isolated within Aegis — agent intelligence for Study A cannot access or influence Study B. Organizational and study-level data boundaries are enforced.
Aegis agent workflows are designed with GCP requirements in mind — including ALCOA+ data integrity principles, risk-based monitoring frameworks, and audit trail obligations.
Aegis is designed to support customer validation documentation requirements. WHPL can provide implementation records and configuration documentation for enterprise validation programs.
Review AI-flagged protocol deviations and data quality issues. Approve or reject query drafts. Maintain data integrity oversight across study sites.
Review site risk intelligence and monitoring signals. Act on SDV alerts. Use AI-generated site visit recommendations to prioritize monitoring resources efficiently.
Review and approve AI-structured QA evidence packages. Oversee CAPA evidence completeness. Maintain inspection-ready evidence organization continuously throughout the study.
Portfolio-level oversight of study quality signals, site performance intelligence, and QA evidence status — without needing to manually compile status reports across sites.
CRONOS Aegis AI Agents are in active development. We are working with a select group of Design Partners — CROs, pharma clinical operations teams, and BA/BE centers — to validate agent intelligence in real trial environments. Design Partners receive early access, direct input into agent development, and preferred commercial terms.
Aegis AI Agents are in development. Capabilities described reflect design intent — not production deployment status. Contact WHPL to discuss current availability and implementation scope for your organization.