Success Story

• The client is a global provider of software and services to the healthcare, pharmaceutical, and clinical research sectors. They offer innovative and user-friendly solutions for collecting and managing clinical trial data.
• Their robust, feature-rich Clinical Trial Management System (CTMS) helps their customers optimize and streamline existing clinical trial processes, reducing errors and costs while improving efficiency.

The client needed a centralized CTMS to streamline trial operations and support reliable electronic data capture across geographically distributed sites.

The system should:

• Allow trial teams to design and manage multi-study clinical programs with phase-specific workflows easily.
• Enable investigators to capture clinical trial data securely from multiple sites and remote locations.
• Ensure data accuracy and integrity through configurable validation and verification workflows.
• Meet 21 CFR Part 11 compliance requirements for auditability, security, and electronic signatures.

We designed a scalable, compliant clinical trial platform that supported Phase I–IV studies with flexible online and offline data capture across single and multi-site trials.

Key solution features included:

• Electronic Data Capture (EDC): Web-based clinical data management with secure, validated electronic data capture.
• Online & Offline Data Entry: Flexible data capture with real-time edit checks and subject-level document uploads.
• Data Review & Query Management: Streamlined discrepancy management, SDV, and reviewer collaboration.
• Batch Data Import: Fast ingestion of laboratory and external data without manual re-entry.
• Custom Reporting: Configurable report designer for standard and study-specific reporting needs.
• Event Notifications: Automated alerts for key data and workflow status changes.
• Advanced Data Query & Export: Powerful filtering, querying, and export to external analytics tools.

• 30–35% reduction achieved in source data verification and monitoring effort.
• Up to 60% faster reporting, advanced querying, and on-demand data exports experienced.
• 35–40% faster query resolution achieved via centralized data review, and streamlined collaboration between investigators, monitors.
• Up to 40% reduction in manual errors and rework attained, resulting from automated validations, controlled data entry, and consistent review processes.