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ClinSoft™

ClinSoft™

ClinSoft™ was created in-house at Innovate Research without any third-party acquisitions or integrations.

The system is compliant with the FDA requirements (21 CFR Part 11) as well as with GCP and HIPAA.

The system is validated and provide a full audit trail.

ClinSoft™ is convenient to use as it ensures quick start-up and close-out thereby saving your precious time during the study and you can make sure that if there are any mid-study updates or amendments made to a protocol that these changes will be promptly adjusted.

  • US FDA 21 CFR Part 11 compliant Validated System
  • Electronic Signatures & Records
  • Secure, Role Based Access
  • Audit Trail
  • Intuitive, User Friendly Interface for CRF & Edit Checks Set-up
  • Re-usable Frameworks for Item, Panels, Visits & Pages
  • Minimum Programming required for Study Set-up
  • High System Scalability
  • Ideal for Multi-Site, Multi-User Trials
  • Study Documents Repository
  • Paper Trial Mode
  • Double Data Entry (DDE)
  • Comparison Reconciliation
  • Batch Edit Checks
  • Customized Reporting & Dashboards
  • Project Dashboards
  • Adhoc Reports
  • Multiple Data Extraction Formats
  • CSV, SAS, Others