Compliance and Security

SimpleTrials’ versatile CTMS toolkit keeps everything you need in one place — while maintaining compliance every step of the way. All of this is hosted on one reliable, web-based CTMS that puts well-designed tools at hand, even on mobile devices. Secure hosting, automatic data backups and an audit trail all come standard.

Get Secure and Reliable Validated Hosting

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SimpleTrials is hosted by a validated hosting provider who provides a qualified server environment to store and process your data.

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The US-based data center has achieved the following: SOC 2 Type II, GSA ISC Level IV, PCI DSS, FISMA, ISO 27001, ISO 9001, EHNAC accredited, GxP & HIPAA qualified.

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Firewalls, state-of-the-art virus and intrusion protection, server monitoring, data encryption and physical security ensure your clinical data is protected with the highest levels of security.

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Full system backups are performed nightly and stored in redundant geographical locations. Our validated hosting provider provides best-of-class reliability, redundancy and high availability.

Access a Proven Platform Backed by Our Quality System

 
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Proven Platform

  • SimpleTrials supports the controls needed for 21 CFR Part 11 Compliance.
  • Designed by clinical experts, built by technology experts-- based on a decade of experience focusing on CTMS applications.
  • SimpleTrials uses the latest, proven web application & database technologies. All personnel are based in the United States.
  • Trial By Fire Solutions has experience integrating CTMS data with 3rd party EDC, IWRS and TMF systems.
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Backed By a Quality System Using Validated Software Processes

  • Agile software development life cycle provides controlled and efficient system building and maintenance.
  • Requirements and design specifications are formally documented.
  • Qualifications are authored with traceability to requirements.
  • Qualification execution results are recorded with objective evidence.
  • Risk analysis and mitigation are performed and documented.
  • Formal change control procedures govern system updates.
 
 

Ready to see SimpleTrials in action?