Life Sciences Industries

Pharmaceutical, Biotechnology, and Healthcare

Clinical Trial Management

GP provided bioMerieux with e-business and IT consulting services in an ongoing effort to develop a custom clinical trial management system that met the FDA compliance requirements of 21 CFR Part 11. GP started with conducting a business needs analysis and developing a functional requirements specification, and evolved through the full software product lifecycle of prototype design, development, testing, validation, and full implementation. This project focused on providing a single system that could manage all aspects of conducting clinical trials, including:

• Data management
• Optical character recognition (OCR) technology
• Contact management
• Inventory management

21 CRF Part 11 Compliance

All software developed incorporated requirements from the 21 CFR Part 11 compliance guidance documentation, including:

• Detailed documented end user requirements, including user log-in and security
• Record change audit trails
• Complete data record retrieval
• Formal documented validation plans

System Features

GP helped our client realize their goals by developing a multi-component system that included:

• Client-server trial management system including both desktop and web-based user interfaces
• Seamless interface with Cardiff Teleforms OCR technology to automate data collection into auto-generated trial database systems
• Software validation protocol to satisfy 21 CFR Part 11 requirements

The successful completion of this project demonstrates GP's ability to manage software projects from concept through implementation using multiple technologies and solutions.