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Trial By Fire Solutions

Clinical trial management and study startup optimization for early-stage drug developers.

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Overview

SimpleCTMS was a web-based Clinical Trial Management System (CTMS) developed by Trial By Fire Solutions, designed to serve early-stage drug developers, sponsors, CROs, and clinical study teams. The platform has reached end of service after operating for over a decade. Trial By Fire Solutions has since transitioned its focus to a second-generation product, SimpleTrials, which combines a full-featured CTMS with an integrated eTMF.

SimpleCTMS was built to provide the benefits of a CTMS without the large upfront financial and resource commitments typical of traditional enterprise systems, and without the inefficiencies of spreadsheet-based trackers. It was intended to offer scalable, cost-effective management of clinical trials, including improvements to study startup costs, performance, and overall study management.

Key Features

  • Designed to be easy to use, flexible, and customizable
  • Runs in standard web browsers with no specialist client software required
  • Supports large, interdisciplinary global teams as well as small studies and teams
  • Portable for use across future studies
  • Well-defined user groups with support for both blinded and unblinded user types within a single system
  • Multi-study and portfolio management capabilities

Platform and Compliance

  • Supports 21 CFR Part 11 compliance requirements
  • Secure cloud hosting in the United States, available from a validated hosting provider
  • Designed by clinical experts and built by technology experts
  • Backed by a quality system using validated software processes
  • Delivered as a Software-as-a-Service (SaaS) model, with monitoring and maintenance included

Support and Services

  • A dedicated client manager provides proactive support and guidance to each customer
  • All users receive technical support from a team of clinical software experts
  • Online video training is included
  • Customized training and professional services are available at additional cost
  • System enhancements and updates are included as part of the service

Following the end of service for SimpleCTMS, Trial By Fire Solutions now offers SimpleTrials, an on-demand subscription-based CTMS for sponsors, CROs, and sites, with plans starting at $399 per month and no long-term commitment required.