September 8th, 2010
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TII Informatix Group
better analysis, better decisions
  • Clinical Applications
    • Early Stage Registries and Clinical Databases
    • Post Approval and Surveillance Studies
    • Health Outcomes Research
    • Serious Adverse Event Reporting Systems
    • Risk Management Systems/RiskMAPS
    • Secure Collaborative Portals
    • Clinical Web Sites
  • Clinical Support Services
    • Clinical Consulting
    • Project Management
    • Clinical Operations
    • Technology Support
    • End User Support and Training
    • Regulatory Compliance
  • Data Management Services
    • Statistical Programming
    • Biostatistics
    • Statistical Analysis
    • Data Migration and Consolidation
    • Data Warehousing and Mining
    • Data Analysis and Reporting
  • Technology Services
    • OPO Connects
    • OPO Security Assessment Service
    • Application Hosting
    • Application Programming
    • Data Security, Privacy and Backup
    • Redundant Data Center
    • Data Recovery
  • About Us
    • Awards
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  • Contact

Regulatory Compliance

TII developed solutions can be fully compliant with 21CFR11, HIPAA and EU requirements and can incorporate robust audit and report capabilities well beyond the minimum required to ensure your important research stays on track. TII also conforms to other, non-governmental industry standards to fully address customer needs. For instance, TII complies with GCP guidelines and adheres to the applicable Federal Information Processing Standards (FIPS) and National Institute of Standards and Technology (NIST) guidelines and specific best practices. The basis for these security and privacy practices and systems is outlined by a well-defined process to achieve certification and accreditation (C&A) in NIST Publications.

TII's General Counsel oversees regulatory compliance issues and coordinates with the quality assurance department and various operational departments to provide guidance and consulting services.


Contact Us

  • Call us today at 1-888-727-8667 or click here to request information on how TII Informatix can deliver innovative and custom clinical solutions for your business.

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