The Challenge

A global biopharma conducting multiple clinical trials faced major challenges in maintaining operational visibility across studies and sponsors. Their existing processes relied heavily on manual monitoring and fragmented data streams, which created inefficiencies in decision-making and compliance tracking. 

Key challenges included:

  • Fragmented Trial Oversight
    Each clinical trial had separate reporting formats and data capture systems, leading to duplication and inconsistent updates between sponsors, CROs, and internal teams. 
  • Delayed Data Consolidation
    Financial, operational, and recruitment data were consolidated manually from multiple spreadsheets and platforms, delaying real-time insights into site and trial performance. 
  • Limited Metric Traceability
    Key trial indicators—such as patient enrollment, protocol deviations, and monitoring visit timelines—were not tracked dynamically, resulting in reactive interventions rather than preventive measures. 
  • Compliance BurdenWith no automated reporting layer, audit readiness was a challenge. Documentation for ongoing trials often required manual compilation before inspections.

Our Solution

Agilisium implemented a Clinical Trial Management (CTM) Dashboard that unified operational, financial, and compliance data in one centralized platform. The solution empowered stakeholders with real-time visibility into study progress and risk signals. 

1
Democratized Data Access
Developed a non-SQL method for querying data within the EDF, eliminating the need for SQL knowledge.

Integrated Data Pipeline

Data from EDC systems, financial trackers, and regulatory logs were integrated into a single data model using Databricks and Azure Data Factory, ensuring consistency across trial records. 

2

Interactive Trial Dashboards

Role-based dashboards were designed to track KPIs such as site performance, subject recruitment status, protocol deviations, and investigator activity—all updated in real time. 

3

Automated Reporting Framework

Regulatory and financial reports were auto-generated and version-controlled, supporting continuous audit readiness with digital traceability. 

4

Risk Monitoring Layer

A visual risk matrix was embedded into the dashboard to flag sites showing irregular performance trends, enabling proactive management by clinical operations. 

5

Self-Service Analytics for Sponsors

Sponsors could filter, visualize, and export their trial data without dependency on analysts, improving agility in communication and oversight. 

Key Impact
60%
Faster operational reporting through automated data consolidation
120%
Real-time performance visibility across 120+ trial sites
The Customer
A global biopharma managing Phase II and III studies across North America and Europe. The primary stakeholders included clinical operations teams, finance controllers, and trial sponsors, all seeking unified visibility into study progress, risk, and resource allocation.

The Outcomes

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Unified Oversight. Real-Time Clarity.

The CTM Dashboard delivered a single, consolidated view of all clinical operations, enabling leadership to act quickly on performance deviations and compliance risks. 

Enhanced Data Governance

All data sources were standardized into a single truth model, reducing manual reconciliation and ensuring traceability. 

Operational Agility

Teams could identify underperforming sites faster, optimize budgets, and reallocate resources dynamically. 

Continuous Compliance

Automated report generation and audit trails ensured inspection readiness at all times. 

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