CTMS Compliance and Architecture

Compliance

21 CFR Part 11 establishes criteria by which the FDA will accept electronic records as equivalent to paper records and electronic signatures as equivalent to traditional handwritten signatures. It is applicable to records required by previously published regulations (predicate rules) as well as new regulations. Predicate rules include Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).

Clinical Force CTMS was designed, developed, tested and released on the basis of 21 CFR Part 11 compliance. Clinical Force complies with 21 CFR Part 11 and other specific guidelines on the use of Electronic systems in Clinical Trial processes, such as GCP and other international standards.

Technical Architecture

Clinical Force knows how important your CTMS system is to your organization including the security of your data. Clinical Force is the first CTMS deployed using a SaaS model. This model is not new to Clinical Applications; several EDC vendors also deploy using the SaaS model.

Clinical Force deploys the CTMS through 8 data centers, with 5 located in North America and 3 in the United Kingdom. The data centers are SAS 7- Type II certified and regularly audited by 3rd parties. Our SaaS deployment model is very secure, offering the following:

  • Access to the application anytime, anywhere
  • Highly secure - 24x7 onsite security, military grade pass cards, biometric scanners
  • Highly available - UPS backup, diesel generators
  • Resilient network - 7 network providers per hosting center

Solution & Platform

Clinical Force was designed and developed as a web based application, using XML and Java based technologies. The system was designed and is deployed to meet the following requirements:

  • Open architecture to ensure scalability and connectivity
  • Modular system, customers buy what they need
  • Data driven frame work
  • High availability
  • Secure
  • Integration to other clinical solutions

The system is hosted on Red Hat servers and supports W3C compliant browsers, including Mozilla, Internet Explorer, Netscape, Chrome, Opera, and Apple/Safari.

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