Data Quality And How It Impacts Clinical Trials

Bringing a therapy to market is a multi-billion-dollar endeavor often hindered by unnecessary friction. A primary source of this inefficiency is poor data quality and a lack of transparency in data flow between sponsors, CROs, and investigator sites.

Several factors currently jeopardize data quality in the life sciences:

• Decentralized Trials: The shift toward varied investigator sites requires rigorous process management to ensure reproducible results.
• Data Security: Manual sharing methods like email risk compromising patient privacy. Secure, compliant environments are essential for redacting protected health information.
• Outdated Technology: Paper-based processes and non-automated systems are prone to human error and risk regulatory rejection from bodies like the FDA.

The shared platform Judi addresses these challenges by providing a secure, cloud-based platform that consolidates data from all sources. By replacing fragmented workflows with built-in quality assurance, Judi streamlines collaboration among stakeholders. The platform ensures data integrity through comprehensive audit trails, automated digital submissions, and 21 CFR Part 11 compliance.