FDX-Powered AI Clinical Quality Intelligence

The Challenge

Clinical trial quality management still operates across fragmented eClinical systems, limiting unified oversight across eTMF, EDC, and protocol compliance workflows. As trial complexity increases under ICH E6(R3) and FDA RBQM expectations, quality teams continue to rely on manual reconciliation, reactive deviation tracking, and disconnected quality reviews.

Key Challenges

Fragmented quality oversight across eTMF, EDC, and CTMS platforms
Manual TMF document classification and QC workflows
Reactive detection of EDC data anomalies and inconsistencies
Limited root-cause visibility for protocol deviations and CAPAs
Inspection readiness assessed late instead of continuously monitored

Our Solution

AI-Powered Unified Clinical Quality Intelligence

Agilisium’s Clinical Forward Deployment Experts (FDX) developed ClinQC — an AI-powered quality platform that unifies eTMF QC, EDC anomaly detection, protocol deviation management, and inspection readiness into a single quality command center.

Built on ICH E6(R3), DIA TMF Reference Model, CDISC, and 21 CFR Part 11 standards, ClinQC enables continuous, AI-driven quality oversight across clinical operations.

AI-Driven eTMF QC & Auto-Classification

‍Automatically classifies TMF documents, detects missing artifacts, misfiling, and ALCOA+ compliance gaps in real time.

CDISC-Aware EDC Anomaly Detection

‍Identifies data inconsistencies and outliers across AE, LB, VS, CM, and DS domains with AI-assisted query generation.

Root-Cause Based Protocol Deviation Analysis

‍Clusters deviations by systemic causes to improve CAPA management and proactive risk mitigation.

Predictive Inspection Readiness Monitoring

‍Continuously evaluates inspection readiness against FDA and global regulatory expectations.

Unified Quality Intelligence Dashboard

‍Provides cross-study visibility into TMF completeness, deviations, anomalies, and compliance readiness in one centralized view.

Key Impact

50–70% Faster Quality Reviews

AI-driven TMF classification and automated queries reduce manual QC effort.

30–40% Improvement in Inspection Readiness

Continuous monitoring helps identify compliance gaps and risks earlier.

The Customer

For a Leading Global CRO - ClinQC was developed to support a leading global CRO managing complex, multi-regional clinical trials across diverse investigator site networks and regulatory environments. The platform enabled: Streamlined TMF quality oversight and ALCOA+ compliance Faster CDISC-based clinical data review and anomaly detection Improved protocol deviation tracking and inspection readiness monitoring Agilisium’s Clinical Forward Deployment Experts (FDX) worked closely with operational and quality teams to align the platform with real-world clinical workflows and compliance requirements.