The Challenge

A global biopharma recognized the need to create stronger operational visibility across their medical functions while keeping the audit requirements continuously maintained. The teams were already performing at scale but wanted a system that could bring together the clinical activity data, audit records, and compliance evidence into one environment.

  • Visibility Across Functions
    Operational information sat across multiple trackers and channels. Leaders required a consistent, real-time view of activities happening across different medical programs. 
  • Audit Readiness and Traceability
    There was a growing need to maintain a structured, traceable record of every medical activity. Documentation and evidence needed to be audit-ready at all times instead of prepared reactively. 
  • Standardization of Clinical Documentation
    Each team used their own way of recording and reporting. This made it necessary to create a standard and repeatable structure to capture medical activities in a compliant format. 
  • Data Confidence for Decision Making
    Data collected from multiple systems needed to be consolidated to create trust in reporting. This would allow leadership to review program health with accuracy and take timely actions. 
  • Operational Oversight and Control
    As more therapeutic programs expanded, there was a need for operational oversight that could scale without creating extra manual workload or duplication. 

Our Solution

Agilisium partnered with the customer to design and deliver a web-based Medical Activity Tracker, built to unify documentation, reporting, and operational visibility in real time. The system was developed under the Clinical Operations function with a clear focus on maintaining compliance traceability and leadership visibility together. 

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

Centralized Audit Trail System

Every activity, approval, or modification was automatically captured with timestamps and version control, giving QA and compliance teams complete visibility across all programs. 

2

Real-Time Dashboards and Operational Insights

Interactive dashboards provided live views into site-level activities, pending documentation, and progress metrics. Program heads could review clinical activities by geography, team, or function instantly.

3

Dynamic Forms and Configurable Workflows

Teams could record clinical activities using dynamic templates that adapted based on user input. Workflows were designed to follow GxP and organizational approval hierarchies.

4

Scalable Application Design

Developed using modern application engineering frameworks, the platform was architected to scale across additional studies. Future integrations like chatbot-based data capture and Power BI dashboards were ideated for extended reporting.

5
Key Impact
Real Time
Documentation and oversight enabled across all medical programs. Continuous audit readiness achieved through built-in traceability and timestamped logs.
Improved
Decision accuracy with unified and structured activity data. Standardized compliance framework applied enterprise-wide.
The Customer
A global biopharmaceutical organization advancing immunotherapy research and development.

The Outcomes

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Continuous Oversight, Complete Compliance

Every clinical activity captured and tracked in real time, removing delays in compliance verification and reporting. 

Unified Source of Operational Truth

A single platform that consolidated all medical operations data, ensuring consistency in how programs are viewed and measured.

Audit Confidence Built-In

Audit logs were automatically generated, reviewed, and archived—making every process inspection-ready without additional preparation.

Faster Leadership Decisions

Operational dashboards empowered leadership with visibility to act on program status instantly, backed by accurate data.

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