Enhancing Clinical Trial Site Risk Management with AI-Enabled Real-Time Oversight

The Challenge

A contract research organization (CRO) wanted to enhance its ability to track operational risks across many studies and sites. Site-level monitoring was complex, and compliance observations or deviations were occasionally identified after initial reporting. They sought a more consistent way to intervene early and maintain operational control.

Risk Assessment
Sites faced frequent operational elements such as protocol deviations, incomplete or inadequate informed consent forms, and consistent GxP documentation.

Fragmented Oversight
Operational and regulatory data were stored in separate systems, which limited visibility for site directors and principal investigators. Identifying these risks early would decrease the cost of remediation effort and increase efficiency.

Delayed Intervention
Without a harmonized scoring model, patterns such as enrolment delays, staff turnover, or recurring audit findings were harder to detect. This delayed the ability of site leadership to act with confidence.

Our Solution

Agilisium designed and delivered a Study Site Risk Assessment Portal that worked alongside the Real-Time Clinical Trial Management System (RTCTMS). This was built to give structure to risk scoring, create visibility across data sources, and ensure readiness for compliance.

Data Integration & Engineering

Built on PySpark and Databricks, the portal brought together data streams such as case report forms, recruitment metrics, staffing logs, and regulatory submissions into one environment.

Real-Time Dashboards

‍Using MS Entra for secure access, site directors and investigators could view live risk metrics, including enrolment pace, protocol deviations, and activation delays, with the ability to drill down to site-level details.

Standardized Scoring Models

‍Risk was scored consistently across all sites, factoring in consent form quality, staff turnover, and audit outcomes. This allowed clearer comparisons and earlier interventions.

Automated Audit Trails

‍Every risk assessment and corrective action was logged digitally. This created a full audit trail, making compliance checks easier and ensuring the CRO was inspection ready.

AI-Enabled Development

‍Delivered a secure, high-quality solution in just 2 weeks with AI-assisted coding, reducing time spent on repetitive tasks.

Key Impact

80%

Development effort reduced through AI-assisted pipelines

Automated data ingestion replaced manual reporting and increased efficiency

The Customer

A midsize clinical research site network that managed multiple study sites. It served clinical operations teams, site directors, principal investigators, and compliance officers who needed reliable visibility into operational risk.

The Outcomes

Compliance-Ready Oversight

A secure, traceable system ensured audit readiness in line with GxP and enterprise standards.

80% Faster Delivery

‍AI-supported coding meant the platform was ready in weeks, reducing both costs and staffing needs.

Up to 90% Reduction in Development Cost

‍The overall cost of development of the platform was ~20K USD, achieved through reduced staffing needs and streamlined effort as a result of AI-assisted coding.