CTG Drives Quality Assurance for Global Pharmaceutical Leader's Clinical Trials

The client is one of the world's leading pharmaceutical manufacturers, with a century-long legacy of developing innovative treatments. Founded in the U.S., they have grown into a global pharmaceutical powerhouse with a company culture focused on research excellence and quality in drug development. 

The Challenge and Opportunity

Like many pharmaceutical companies, the client faced increasing complexity in their clinical trials management while needing to maintain strict regulatory compliance. While internal teams could handle study setup, they needed an independent third party to validate their clinical trials management system to ensure unbiased quality assurance and regulatory compliance. They needed a partner who could:

• Ensure accurate study setup validation before first patient visits
• Maintain perfect audit compliance while handling increasing study complexity
• Scale testing capacity to match growing global operations
• Provide consistent, reliable support across multiple study types 

The Solution and Results

Since 1991, CTG has partnered with the client to provide comprehensive testing and validation services for their clinical trials management framework. Operating through a structured four-gate process, CTG validates studies and ensures each trial is correctly configured before patient enrollment begins.

Key components include:

• Requirements Review and Approval: Comprehensive validation of study requirements  
• Build and Test Planning: System configuration, build review, and test case development  
• Testing Execution: Systematic testing to verify proper system functionality  
• Production Migration: Final verification of accurate study deployment to production

The team has evolved from using manual IVR (Interactive Voice Response) systems to modern web-based solutions. Notably, the testing process has never received an audit finding. CTG's scalable expertise is demonstrated by their growing team of experienced testers, including:

• Core team members with 20+ years of experience
• Global support capability with team members in the U.S. and India
• Continuous recruitment to match client's expanding needs
• Proven track record of staff retention and knowledge preservation

To maintain quality while improving efficiency, CTG implements:

• Microsoft SharePoint for study forecasting and tracking
• Teams and Planner for coordinated task management
• Excel-based tools for requirements comparisons
• Continuous process improvement methodologies

Through three decades of partnership, CTG has evolved alongside the client's growing clinical trials program, consistently delivering quality testing services while adapting to increasing study complexity. As the client continues to expand their global operations and grow study volumes, CTG remains a trusted partner in ensuring the quality and compliance of their clinical trials management system.