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 Hosting for your Data


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


The US-based data center has achieved the following credentials and certifications: SOC 1/2/3,  PCI DSS, ISO 27001 and ISO 9001.


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.


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


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.

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?