GxP Data Integrity

As clinical development sponsors increasingly embrace technology, they engage numerous vendors and services, resulting in a complex data ecosystem. However, many lack clarity on data integrity requirements and regulations, jeopardizing their development programs. At Halloran, our subject matter experts define data strategies and ensure inspection-ready data.

We support various systems and services: 

• Electronic master files
• Regulatory information management systems
• Clinical trial management systems
• Electronic data capture
• Data visualization
• Electronic patient-reported outcomes
• Electronic clinical outcome assessments
• Electronic quality management systems
• Electronic document management systems
• Electronic signatures

With the surge in technology adoption, sponsors invest in diverse systems and services across all development phases, leading to a complex data ecosystem and massive data generation and transfer. Regulatory bodies, particularly the U.S. Food and Drug Administration (FDA), are increasingly focused on data integrity and sponsor oversight. Our consultants excel in data integrity across domains, crafting strategies to provide consistent integrity and inspection readiness.