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eIQ Review

AI-enabled anomaly detection and data review automation for clinical trials, reducing manual review by over 50%.

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Overview

eIQ Review is an AI-enabled clinical data review and query automation system, part of the elluminate Clinical Data Cloud®. Designed for data management teams, medical monitors, medical directors, and clinical operations professionals across biotech, pharma, and CRO organizations, eIQ Review leverages advanced machine learning to predict and proactively manage data issues — both operational and context-driven — ensuring data integrity in a more efficient and scalable way. Teams using eIQ Review can automate over 50% of manual data review tasks.

As clinical trial data volumes continue to grow across diverse sources, even the most comprehensive review plans can miss critical issues, leading to costly errors and delays. eIQ Review transforms data review processes by combining intelligent anomaly detection with a user-friendly, centralized platform that enables near real-time review and action.

AI/ML-Powered Anomaly Detection

  • Advanced anomaly detection models predict and identify subjects with anomalous or atypical values across all data sources.
  • Review objectives are automated to detect anomalous data, reducing the volume of manual review required and enabling reviewers to focus on the most critical data domains.
  • Reviewers receive a prioritized list of anomalous subjects or atypical values and can drill down into underlying subject data before taking follow-up action.
  • Issues and queries can be created directly within eIQ Review, streamlining the adjudication and resolution workflow.
  • Adjudication metrics are fed back into the machine learning models to continually refine and improve detection performance over time.

Optimized Time to Value

  • eIQ's intelligent AI models are trained out-of-the-box, requiring minimal study start-up time.
  • Self-serve, user-friendly configuration allows models to be deployed and used from day one of a study.
  • Multiple models are available to support use cases for clinical data review teams, medical directors, and medical monitors across therapeutic areas and trial phases.
  • The novel machine learning methodology allows the same models to be applied across multiple studies, therapeutic areas, and both safety and efficacy domains.

Key Platform Capabilities

  • eIQ Review is study data agnostic and embedded within the elluminate Clinical Data Cloud, enabling seamless integration from data ingestion through insights to issue management.
  • AI-powered model analytics and performance monitoring dashboards provide ongoing visibility into model effectiveness and query outcomes.
  • A full audit trail of all findings is maintained within eIQ Review, supporting compliance and traceability requirements.
  • The platform supports near real-time data review and subsequent action, all managed from a single centralized location.
  • Existing elluminate platform functionality supports the adjudication of anomalies and the subsequent generation of issues and queries.

eIQ Review is purpose-built for clinical teams seeking to decrease cycle times and increase productivity without sacrificing data quality. As a component of the elluminate Clinical Data Cloud, it complements other platform products — including Data Central, Risk-Based Quality Management, and the Statistical Computing Environment — to deliver a fully integrated, data-driven clinical trial management ecosystem.

Meta

Domain
Clinical Trial Management
Subdomain
Clinical Data Review & Monitoring
Software type(s)
Analytical Platform
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP
Tag(s)
Uses AI