ClinsoftTM

KEY SYSTEM HIGHLIGHTS

  • US-FDA 21 CFR Part 11 Complaint System
  • Application Program Interface (API) based Modular System, ease of adding new modules
  • ODM Compliant Data Model with Common Data Tables and Uniform Data Structure
  • Full Scale or Modular Deployment, Fully Configurable as per Sponsor Requirements
  • Fully Validated with comprehensive IQ, OQ, PQ documentation
  • Secure, Roles Based Access & Authority Checks, Strong System Authentication & Security
  • Electronic Signatures & Records
  • Audit Trail for all System Activities
  • System Based Alerts
  • Study Planning
  • Scheduling
  • Monitoring

21 CFR Part 11 Compliant, Web-Enabled eClinical Suite with integrated Clinical Trial Management, Clinical Data Management, Electronic Trial Master File and Operational Analytics functionalities designed especially to support Innovate Research’s end-to-end Global Clinical Operations, Data Management and Project Management requirements.

The system supports end-to-end operational activities from project set-up, planning, budgeting, execution, performance analytics and reporting for all clinical trial, apart from storing all clinical and operational enterprise data as well as electronic trial master files in a single repository.

 

Contact

Within India

0 120 4797021

Outside India

+91 120 4797021

G-07, Newbridge Business Centre, 1st Floor,
Inox Tower-B, Plot No. 17, Sector-16A, Film city,
Noida, India 201301

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