Electronic Data Capture
Intelligent eCRF design, real-time validation, and ALCOA++ compliant data management, from first patient in to database lock.
Capture Clean Data the First Time
Reduce queries by 60% with intelligent validation and guided data entry.
Visual eCRF Builder
Drag and drop form designer with 40+ field types, conditional logic, auto-calculations, and cross form edit checks. Build complex CRFs in hours, not weeks.
Real-Time Validation
Client-side and server side validation fires instantly as data is entered. Range checks, consistency rules, and custom edit checks catch errors before they become queries.
ALCOA++ Data Integrity
Complete audit trail for every data point, attributable, legible, contemporaneous, original, and accurate. Every change is timestamped, signed, and reason-coded.
CDISC ODM & Dataset-JSON Export
Native CDISC ODM export with automated SDTM/ADaM mapping support. Generate submission ready datasets with built in compliance validation.
Medical Coding
Integrated MedDRA and WHODrug coding with auto-suggest, batch coding, and version management. Code adverse events and medications directly within the eCRF.
Query Management
Automated query generation with configurable rules, site facing resolution workflows, and real-time query metrics. Track open queries across studies and sites.
Lab Data Integration
Automated central and local lab data import with reference range mapping, flagging, and reconciliation. Support for HL7 and CSV lab data formats.
How It Works
From form design to database lock in three steps.
Design Your eCRFs
Build electronic case report forms with the visual designer. Add validation rules, conditional logic, and cross form checks, then preview exactly what sites will see.
Capture & Validate
Sites enter data through an intuitive web interface. Real-time validation catches errors instantly, automated queries flag discrepancies, and audit trails record everything.
Lock & Export
Run database cleaning checks, resolve outstanding queries, lock the database, and export CDISC compliant datasets ready for statistical analysis and regulatory submission.
Ready to Modernize Your Clinical Trials?
Join leading sponsors, CROs, and research sites using Vitruvian Shield to run faster, smarter, and more compliant trials.
Or contact our team for a personalized walkthrough.