ClinDatrix Infrastructure

Office Space Description

ClinDatrix occupies 8,300 square feet on the second floor (for security) of a modern office building.

IT Systems

ClinDatrix maintains and continues to invest heavily in advanced technologies and systems to manage the capture and delivery of large volumes of clinical data. Our secure computerized systems are designed to comply with FDA 21 CFR Part 11 regulations. Our network is centered around Windows Server 2008.

In addition ClinDatrix employs the following practices to our information technology investments:

  • Network infrastructure management
  • Defined Standard Operating Procedures
  • Backup disaster recovery planning
  • Database software change control
  • System validation support (IQ/OQ/PQ)

Clinical Database Management System

  • Fully validated - IQ / OQ / PQ
  • Fast and easy database and screen setup
    • Data dictionary library
    • Derivatives
    • Edit checks library
  • Integrated with scanning technology for parallel processing of data management activities
  • Double independent data entry
    • From paper or electronic images
    • Integrated image viewer
  • Query management system
  • Random data selection for quality control
  • Built-in data review tool
  • Automated CRF print reports
  • Electronic audit trail
  • System security
    • Time out / re-login in Windows
    • Ergonomic password
    • Modules installed for designated roles

Clinical Data Management Department

  • Standards
    • Document templates
    • Global libraries
    • Coding dictionaries
    • Job descriptions
    • Training strategies
    • Training records
    • Signoff / approval forms
  • Equipment and Systems
    • Validated Clinical Database Management System
    • Proprietary logging and tracking system
    • Proprietary training system
    • Licensed and certified in MedDRA
    • Licensed in SAS
    • Dedicated data server
    • Dedicated scanners
    • Desktop and portable workstations

Profile

ClinDatrix is a CRO guided by the successful career experience and extensive knowledge of its founders, Louise M. Murphy, PhD, MBA, President and CEO, and Brian G. Murphy, BEng, PhD, CFO and Chairman of the Board. Utilizing strong project management skills and techniques, ClinDatrix leverages knowledge and expertise in partnership with its clients to yield excellent clinical research services.

ClinDatrix infuses quality throughout all clinical phases of projects using:

  • Experienced and knowledgeable professionals
  • State-of-the-art systems
  • Validated processes
  • Implemented standards

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