ClinSoft

Electronic data capture for clinical trials with FDA 21 CFR Part 11 compliance, audit trails, and multi-site study management.

Overview

ClinSoft is an Electronic Data Capture (EDC) system developed in-house by Innovate Research, built without third-party acquisitions or integrations. It is designed for use in clinical trials and is compliant with FDA 21 CFR Part 11, GCP, and HIPAA requirements. The system is validated and provides a full audit trail, making it suitable for regulated research environments.

ClinSoft supports quick study start-up and close-out, and accommodates mid-study protocol updates and amendments. It is suited for multi-site, multi-user trials and is designed to require minimal programming for study 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 Design 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
Ideal for multi-site, multi-user trials
Batch edit checks

Data Management Features

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

Reporting and Data Export

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

ClinSoft is offered by Innovate Research, based in Noida, India. The platform is also available alongside PageOne, the company's IWRS solution, for broader clinical trial management needs.