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CASE STUDY

Streamlining sensitive Pharmacokinetics data review through automated anomaly detection

industry-iconCLIENT :Confidential
industry-iconINDUSTRY :Pharmaceutical
industry-iconDURATION :4 months
CLIENT :
Confidential
INDUSTRY :
Pharmaceutical
DURATION :
4 months

Business case

A global pharma giant wanted to optimize, manage, and review sensitive Pharmacokinetics (PK) data efficiently, as manual checks across clinical trial sites were slow, often missing critical abnormalities. The current data checks were not standardized and reviewing large datasets manually meant inconsistencies in how data was interpreted and anomalies flagged. Moreover, without clear visualization tools, it was difficult for teams to quickly spot trends, patterns, or outliers, resulting in slower, less informed decision-making. Delays or inaccurate detection of anomalies could bring significant regulatory risks affecting compliance in a highly regulated environment like clinical research.

Adding to the complexity was the lack of centralized access control and audit mechanisms. There was no easy way to track user logs, raising concerns around data governance and accountability. Additionally, the inconsistent and often unsecured handling of sensitive clinical data increased the risk of breaches, undermining trust and regulatory readiness.

To face these challenges, the client wanted a custom application that could centralize and automate abnormality detection without compromising data security. One which allows users to scan sensitive files, apply threshold logic, and quickly identify files with potential issues, while ensuring that only specific, non-sensitive data points are visualized.  

Our solution

Keeping in mind the complex clinical data management needs, i2e developed a custom application to automate PK data scanning for abnormalities, visualizing detected issues, setting threshold parameters, and tracking user actions through audit logs. The solution also integrated a Secure File Transfer Process (SFTP) for Clinical Data Administration and Management (CDAM05).   

Key features 

  • Automated abnormality scanning : Scans PK data automatically from a secure drive or manual upload, reducing manual effort and speeding up reviews.
  • Subject-level insights in a dashboard view  : Highlights abnormalities per subject, enabling quick issue identification and focused analysis.
  • Privacy-first data handling : Displays only selected, non-sensitive abnormality data with visual summaries—never storing or exposing full datasets, ensuring sensitive clinical data remains protected.  
  • Audit logging and tracking : Every user action is tracked through audit logs, providing transparency and accountability for those who accessed or interacted with the data.
  • Box plot visualization : Visualizes abnormalities across interventions using box plots for clear trend analysis and outlier detection.
  • Threshold & user management : Allows administrators to adjust thresholds and manage user settings and privileges for secure and compliant operations. 

Challenges overcome

  • Integrating the solution with the organization’s centralized access and compliance systems needed cross-team coordination and infrastructure alignment. 

Benefits

  • Faster data reviews by automating abnormality detection, cutting manual errors.
  • Clearer insights with subject-level drilldowns and intuitive visualizations.
  • Ensures compliance with built-in audit trails and secure, role-based user tracking.
  • Provides secure and controlled approval-based data access  
  • Secures sensitive data handling by enforcing strict governance controls. 

Results

Results