OBJECTIVES
The Clinical Trial Software is a comprehensive eSource clinical research and early-phase trials system designed to streamline and enhance the clinical trial process. With features like real time data capture, optimized volunteer recruitment, and regulatory compliance, it plays a critical role in accelerating clinical drug development. This case study explores the testing strategy employed to ensure the Clinical Trial Software delivers on its promise of providing Day 1 results with seamless functionality.

BUSINESS OBJECTIVES
1. Ensure System Reliability: Guarantee stable and error-free performance for on-site and cloud-based deployments.
2. Validate Real-time Data Capture: Verify the accuracy and immediacy of data        collected from bedside and remote sources.
3. Regulatory Compliance: Confirm adherence to 21 CFR Part 11 and other industry standards.
4. Support Efficient Trial Management: Validate functionalities such as volunteer recruitment, data review, and compliance management

 TESTING APPROACH

Phase 1: Pre-Testing Preparation
 - Define test objectives and success criteria for critical features.
 - Establish test environments for both on-premise and SaaS deployments.
 - Create synthetic datasets and anonymized production data.

Phase 2: Functional Testing
 - Positive Test Cases: Validate expected functionality using standard inputs.
 - Negative Test Cases: Simulate malformed data inputs and network disruptions.
 - Boundary Testing: Stress test limits, such as maximum patient data uploads.

Phase 3: User Acceptance Testing
 - Conduct real-world testing with clinicians and site managers.
 - Refine workflows based on user feedback.

AT A GLANCE CHALLENGES
 - Complexity and software support for multiple devices like Mobile, Laptops, Medical devices, tablets.

 - Multisite data synchronization Regulatory compliance.

SOLUTIONS
 - We brainstorm on Test strategy, Test Coverage and prepared Test plan and followed the process
 - We achieved Delivery Deadlines
 - No P1, P2 defect slippage
 - Working in Agile Team with communication and transparency

BENEFITS

 - Functional Validation: All core functionalities met the defined success criteria, including real-time data capture and multisite synchronization.
 - Regulatory Compliance: Successfully validated adherence to 21 CFR Part 11 and other applicable standards.
 - Enhanced User Experience: Comprehensive testing ensured easy adoption by users.