PageOne IWRS

Interactive Web Response System for clinical trial patient randomization, dosing, and inventory management with FDA 21 CFR Part 11 compliance.

Overview

PageOne IWRS™ is an Interactive Web Response System developed in-house by Innovate Research, built without any third-party acquisitions or integrations. It is designed for use in clinical trials, supporting multi-site and multi-user study environments. The system is compliant with FDA 21 CFR Part 11, GCP, and HIPAA requirements, is fully validated, and provides a complete audit trail.

PageOne IWRS™ is designed to support quick study start-up and close-out, and accommodates mid-study protocol updates and amendments with prompt adjustments to the system configuration.

Compliance and Security

US FDA 21 CFR Part 11 compliant validated system
Electronic signatures and records
Secure, role-based access control
Full audit trail

Study Setup and Configuration

Intuitive, user-friendly interface for CRF and edit checks setup
Re-usable frameworks for items, panels, visits, and pages
Minimum programming required for study setup
High system scalability
Suitable for multi-site, multi-user trials

Data Management Capabilities

Study documents repository
Paper trial mode
Double data entry (DDE)
Comparison reconciliation
Batch edit checks

Reporting and Data Export

Customised reporting and dashboards
Project dashboards
Ad hoc reports
Multiple data extraction formats including CSV, SAS, and others

PageOne IWRS™ is offered alongside Innovate Research's ClinSoft EDC platform. The company is based in Noida, Uttar Pradesh, India, and can be contacted for demo requests through their business development team.