CTMS Team | Clinical Data Modernization and Unified Oversight

The Challenge

The client, a global biopharma, wanted to modernize how its study data was viewed, validated and shared between its own teams and partners. As the scale of studies grew, the client saw a need to manage the volume of operational data to make it consistent. Every team had data coming in from different systems that reduced the visibility of operations, data management and compliance functions.

Expanding Study Environment
With multiple ongoing studies, it was important to have a single platform that could bring together all operational data and help track progress across programs.

Validation at Scale
Data validation needed to move faster and stay standardized. The process had to evolve into something more proactive than reactive, so that quality was maintained without manual effort.

Optimizing System Performance
The clinical data application needed to respond faster, scale better and provide quicker access to study information, while maintaining reliability.

Partner Coordination
As multiple partners were involved, data access and visibility had to stay clear between all of them, making collaboration smoother and governance stronger.

Our Solution

Agilisium worked together with a global biopharma and redesigned the Clinical Trial Management and Monitoring System (CTMS) to make it unified, faster and ready for the future.

Unified Data Foundation

Study data was brought together into one environment that can be accessed by all the key users. This helped ensure that information remains consistent across teams and programs.

Performance Reengineering

The platform was built with improved application architecture to increase responsiveness and stability for all study users.

Automated Validation

Validation logic was automated, reducing dependency on manual checks. This ensures quality remains consistent while freeing time for teams to focus on insights.

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Scalable Framework

The new system was designed to extend across new therapeutic divisions, keeping the same consistency and visibility for future programs.

Key Impact

Better Performance and Speed

Teams could access, validate and review data faster than before, helping operations stay efficient.

Automated Data Quality

Automating validation improved accuracy, reduced manual handling and allowed teams to act on insights in real time rather than waiting for batch processes.

The Customer

A global biopharmaceutical company engaged in large-scale research programs across multiple therapy areas. The primary users were clinical operations leads, data managers and compliance teams.

The Outcomes

Unified Study Oversight

All study data can now be viewed in a single platform, improving visibility across programs and giving study teams the context they need in real time.