VeriDose is developed as a clinical trial data management platform automating collection, validation, and regulatory-ready reporting
Cutting Clinical Trial Data Review Time by 60% with Automated Validation
Key results from this project
Reduction in Data Review Time
Fewer Data Queries Raised Post-Entry
Project Summary
VeriDose Clinical approached Hatzs to modernize how trial data moved from investigator sites to regulatory submission. The goal was a platform automating data capture and validation across trial sites, catching data quality issues immediately instead of during a slow, manual review months later.
Given the regulatory weight of clinical trial data, VeriDose needed a system built around validation and traceability from day one. Hatzs worked with the clinical operations and biostatistics teams to ensure every automated check matched their existing quality standards.
High performance components for demanding applications
They needed a technology partner to support its digital strategy
Given the regulatory weight of clinical trial data, VeriDose needed a system built around validation and traceability from day one. Hatzs worked with the clinical operations and biostatistics teams to ensure every automated check matched their existing quality standards.
- Automated Data Capture: Structured intake of trial data directly from investigator sites, reducing manual transcription.
- Real-Time Validation: Automated checks flagging data quality issues as they're entered, not weeks later.
- Audit Trail & Traceability: A complete, immutable record of every data change for regulatory submission.
Our Approach & Solution Delivery
VeriDose Clinical approached Hatzs to modernize how trial data moved from investigator sites to regulatory submission. The goal was a platform automating data capture and validation across trial sites, catching data quality issues immediately instead of during a slow, manual review months later.
Key implementation aspects included:
Automated Data Capture
Structured intake directly from investigator sites, replacing manual transcription with validated digital entry.
Real-Time Data Validation
Automated checks that flag inconsistencies and quality issues as data is entered, instead of during a slow retrospective review.
Regulatory-Ready Audit Trail
An immutable, fully traceable record of every data change, built to withstand regulatory audit from day one.
Results & Outcomes
VeriDose Clinical now catches data quality issues in real time instead of during a slow manual review, shortening the path to submission.
- Automated Data Capture: Structured intake of trial data directly from investigator sites, reducing manual transcription.
- Real-Time Validation: Automated checks flagging data quality issues as they're entered, not weeks later.
- Audit Trail & Traceability: A complete, immutable record of every data change for regulatory submission.
- Site Coordination Tools: Visibility into enrollment, protocol deviations, and site performance across all trial locations.
- Regulatory-Ready Reporting: Export formats aligned with submission requirements to reduce last-mile preparation work.
Given the regulatory weight of clinical trial data, VeriDose needed a system built around validation and traceability from day one. Hatzs worked with the clinical operations and biostatistics teams to ensure every automated check matched their existing quality standards.
Data issues used to surface months later during review, when fixing them was expensive and slow. Now we catch them the day they happen, at the site, before they ever become a problem.
