SimpleTrials

SimpleTrials is a clinical trial management system (CTMS) and electronic trial master file (eTMF) solution offered by Trial By Fire Solutions. According to the vendor, it is designed to assist sponsors, contract research organizations (CROs), and sites in effectively planning, managing, and tracking their clinical trial portfolios. SimpleTrials is suitable for organizations of all sizes, from small startups to large pharmaceutical and biotech companies. It is utilized by various professionals and industries including clinical trial managers, study coordinators, data managers, site investigators, CROs, pharmaceutical and biotechnology companies, academic research institutions, and medical device companies.

Key Features

Site Startup and Subject Tracking: According to the vendor, SimpleTrials provides a customizable startup tracker for managing site selection through enrollment activities. It integrates with subject screening and enrollment records and calendar events, allowing for efficient tracking of screening, screen failure, and enrolled subjects with export capability. Users can customize tracking views with custom columns and picklists.

Contacts and Organizations: SimpleTrials allows users to effectively manage contacts and organizations at the portfolio level. It offers visibility of sites, sponsors, vendors, IRBs, and CROs, and provides detailed views, search, and export capabilities. Additionally, contacts and organizations can be easily integrated with study and site teams.

Documents and eTMF: SimpleTrials supports DIA reference models or custom eTMF models, enabling users to upload files with 21 CFR Part 11 compliant electronic signatures. It allows for tracking of document details such as name, version, and status, and provides expiration tracking with role-based and person-specific alerts.

Real-Time Study Analytics and Dashboards: The system offers dashboard charts for visualizing study performance and key metrics, providing basic study analytics for quick reference. Users can export charts for external use and receive in-application alerts for managing key events.

Calendar and Monitoring: SimpleTrials features a calendar view for displaying portfolio and study-level activities, including support for site visits, subject visits, and company/team events. It also offers export to Outlook (iCal) functionality and action items tracking with alerts.

Custom Fields and Trackers: Users can easily add custom fields to trackers without programming, allowing for re-ordering and hiding of tracker columns. The system offers data type and style customization for custom columns, as well as customization of tab view for single or multiple studies.

Ad-hoc Reporting Engine: According to the vendor, SimpleTrials provides the flexibility to create custom reports across functional areas of the CTMS. It supports both standard and custom report definitions, and allows for multi-study or single-study data outputs. Users can take advantage of filtering, grouping, and sorting options to generate the desired reports.

Planning and Milestones: The system facilitates task and milestone tracking with an integrated Gantt chart. It allows for tracking of targets, actuals, and baseline dates, and supports percent complete tracking with alerts. Users can import and copy milestones and tasks for enhanced planning efficiency.

Site Contracts and Payments: SimpleTrials enables users to define study-level contract templates for countries and sites, and efficiently manage multiple contracts per study and site. It tracks visit progress, data progress, and fees, and generates detailed invoices while providing payment tracking functionality.

Electronic Visit Reports: Users can create user-defined templates for multi-study use, and utilize author and reviewer workflows for drafting and approval of electronic visit reports. The system allows for document attachments for related essential documents and letters, and provides in-application workflow notifications and email alerts for seamless collaboration.