CliniOS

User Personas

1. Principal Investigator (PI): Oversees the clinical trial, ensures compliance with protocols.
2. Physician: Administers the drug and monitors patient responses.
3. Research Nurse: Assists in drug administration and sample collection.
4. Phlebotomist: Collects blood samples and ensures correct handling and labeling.

Key Features

1. Error Warnings: Alerts for incorrect time points and vacutainer usage.
2. Protocol Configuration: Easy setup of study protocols before sample collection.
3. Batch Process Management: Handles multiple samples efficiently, especially during peak times.
4. Barcode Generation: Unique barcodes for subjects, vacutainers, and aliquots to ensure traceability.

My Roles and Responsibilities

• User Interface (UI) Design: Created and implemented a user-friendly interface for CliniOS, ensuring accessibility across all devices, including iPads, iPhones, and other browsers.
• User Experience (UX) Design: Developed a seamless and intuitive user experience for the blood sampling process. Collaborated closely with the development team to ensure the UX design was effectively translated into a working product.
• Prototyping and Wireframing: Created prototypes and wireframes for CliniOS’s features, such as protocol configuration, error warnings, and barcode generation.
• User Research: Conducted user research to understand the needs and pain points of clinical trial staff. Used these insights to inform the design process.
• Usability Testing: Conducted usability tests to gather feedback and iteratively improve the design. Ensured the platform was easy to use and met the needs of the users.
• Collaboration: Collaborated with cross-functional teams, including developers and product managers, to ensure CliniOS met business goals and user needs.
• Design Systems: Developed and maintained a design system for CliniOS to ensure consistency across the product.
• Cloud-Based Design: Leveraged the convenience, security, and mobility of the cloud (Microsoft Azure) in the design process. Ensured the platform could scale with the organization as it grew.

Design Process

1. Research and Analysis
   • Conducted interviews with clinical trial staff to understand pain points.
   • Analyzed existing systems to identify gaps and opportunities for improvement.
2. Wireframing and Prototyping
   • Created wireframes to outline the basic structure and flow of the application.
   • Developed interactive prototypes to visualize the user journey and gather feedback.
3. User Testing
   • Conducted usability testing with actual users to identify issues and gather insights.
   • Iterated on the design based on feedback to improve usability and functionality.
4. Final Design
   • Implemented a clean, intuitive interface with clear navigation.
   • Ensured that error warnings are prominent and easy to understand.
   • Integrated barcode scanning and generation features seamlessly into the workflow.

Results

• Error Reduction: Significant decrease in manual errors during the blood sampling process.
• Improved Efficiency: Faster sample collection and processing times.
• Enhanced Compliance: Better adherence to study protocols.
• Increased Traceability: Easy tracking of samples through unique barcodes.

Conclusion

CliniOS successfully addresses the critical needs of clinical trial staff by providing a robust, user-friendly solution for managing the blood sampling process. The application not only reduces errors but also enhances overall efficiency and compliance, making it an invaluable tool in the clinical trial EDC process.