SimpleCTMS

Clinical trial management and study coordination for early-stage drug developers, with multi-study portfolio support and 21 CFR Part 11 compliance.

Overview

SimpleCTMS was a web-based Clinical Trial Management System (CTMS) developed by Trial By Fire Solutions, designed for early-stage drug developers and clinical study teams. It aimed to provide the core benefits of a CTMS without the large upfront costs of traditional enterprise systems or the limitations of spreadsheet-based tracking. SimpleCTMS has reached end of service after operating for over a decade; the company is now focused on its second-generation product, SimpleTrials, which combines a full-featured CTMS with an integrated eTMF.

The platform was built to support a range of team sizes and study types, from small studies to large, interdisciplinary global teams, and was positioned as a scalable, cost-effective solution for managing clinical trial performance and study startup.

Features

Flexible and customizable interface designed for ease of use
Runs in standard web browsers with no specialist client software required
Supports both large, interdisciplinary global teams and smaller studies
Portable for reuse 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 available in the US through a validated hosting provider
Backed by a quality system using validated software processes
Delivered as a Software-as-a-Service (SaaS) model, with monitoring and maintenance included
Designed by clinical experts and built by technology experts

Support

Dedicated client manager providing proactive support and guidance
Technical support from a team of clinical software experts available to all users
Online video training included
Customized training and professional services available at additional cost
System enhancements and updates included as part of the service

Trial By Fire Solutions' successor product, SimpleTrials, is an on-demand, subscription-based CTMS for sponsors, CROs, and sites, with plans starting at $399 per month and no long-term commitment required.