Features

SimpleTrials’ versatile fully validated CTMS keeps everything you need — worksheets, documents, calendars, contacts, schedules, payments, milestones and more — in one feature-rich, scalable package all while maintaining compliance every step of the way. It’s the industry’s first on-demand, subscription-based CTMS for sites, vendors and sponsors.

Plans start at $399/month. With SimpleTrials, you subscribe, sign in and get to work with a comprehensive toolkit with no long-term commitments.

Product Overview | Product Features | Data Integrations | Support

Product Overview

Why purchase individual eTMF, site payment and CTMS products when SimpleTrials CTMS includes functionality for all three at a fraction of the price? SimpleTrials also can be easily integrated with external EDC systems.

eTMF included – DIA models available, file upload, detailed tracking, alerts, multi-file upload and zip file download come standard
Data imports included – Portfolio and study level (e.g. Sites, Contacts, Startup, Subjects, Action Items, etc.)
Site payments included* – Country level contract templates, site contracts, invoicing, tracking, reporting
EDC integration capabilities included* – multiple vendors and flexibility by study
Data exports, built-in CTMS reports, and ad-hoc reporting included.
Add custom fields and expand system fields included - add new tracker columns, expand system picklist choices, column rename/show/hide, manage for single or multiple studies
Custom tracker capability included* - build your own trackers for portfolio, study, site, team and subject content
Email and in-app alerts included – manage visit reports, documents, milestones, action items and more

User management includes role-based User Access controls, data access limitations (e.g. study and portfolio level), study site assignments

*Items quickly available in SimpleTrials with additional purchase or Premium Subscription Plan

Product Features

Access the robust clinical trial management tools you need. SimpleTrials can adapt to the size of your projects and teams, from one study to a whole portfolio.

Site Startup and Subject Tracking

Comprehensive and customizable startup tracker, integrated with your site list
Site Startup Tracking manages activities from site selection through enrollment
Integration with subject screening & enrollment records and calendar events (e.g. sync SIV dates, FPS and FPI dates)
Screening, Screen Failure and Enrolled subject tracker with export capability
Subject Visit Tracking, integrated with your protocol visit definitions and screen fail reasons
Easily customize tracking views with custom columns and custom picklists for workflow needs
Import external data sources quickly with import template with instructions
Ability to integrate with external EDC systems
Support for unscheduled visits

Documents and eTMF

Support for DIA reference models, SimpleTrials reference model, or build your own eTMF model
Define site essential documents required for activation, study closure, and EC submission
Ability to upload files directly to the CTMS with 21 CFR Part 11 compliant electronic signatures
Manage tracking details such as common name, version, and status or build your own columns
Expiration tracking with role-based and person-specific alerts
Ability to track study-specific and other general documents by study
Approved electronic visit reports (EVRs) and attachments automatically posted to eTMF
Zip download available for posted files including organizational view
Tracking and folder views plus document search feature for ease of navigation
CTMS Reports for essential documents, folders, change history and custom tracking fields

Calendar and Monitoring

Calendar view displays comprehensive portfolio and study level activity at a glance with electronic visit report (EVR) insight
Supports site visits (projected and actual), subject visits (projected and actual) and general company/team events (e.g., holidays)
Supports export to Outlook (e.g. iCal)
Integrated with the Site Visit Tracking, which provides workflow-based tracking of the visit report, confirmation and follow-up letters, and custom tracking needs
Action items tracking for site visits and study team activities with alerts
Includes CTMS Reports and KPI performance metrics for monitoring plan timelines

Ad-hoc Reporting Engine

Reporting interface allows custom reports across functional areas of the CTMS
Standard (default/canned) report definitions are provided so you can generate reports immediately
Custom reports can be defined and saved using a simple interface
Reports allow multi-study or single-study data outputs
Common metrics and reports supported for startup tracking, milestones, site visit reports, site essential docs, recruitment, contracts and payments
Supports a variety of filtering, grouping and sorting options by report
Custom columns in study views can be included
Excel, CSV, PDF and HTML output supported

Planning and Milestones

Task and Milestone tracking includes integrated Gantt chart
Track targets, actuals and baseline dates
Supports percent complete tracking, integrated alerts and export
Set priority, responsible party and dashboard input records
Import external data using detailed import template with instructions
Project features include definition of predecessors and lag between tasks
Use the default milestones and tasks or create your own set
Copy your milestones and tasks between studies for consistency across your program

Contacts and Organizations

Comprehensive contact & organization management features at the portfolio level
Visibility of sites, sponsors, vendors, IRBs, CROs
Detailed views, search and export capabilities available
Contact integration for study and site teams within studies
Integration of the organizations to site, study team and vendor records within studies
Global, site-specific and alternate address management for contacts and study materials
Import contacts and organizations using import template with instructions

Real-Time Study Analytics and Dashboards

Dashboard charts provide visualizations of study performance like site startup and enrollment activities
Basic study analytics, like target vs. actual number of countries, sites, screens and enrolled subjects are visible for quick reference
Charts can be exported for use in external documents and presentations
In-application alerts for users to manage key events such as action items, visit reports, document expiration, study milestones

Custom Fields and Trackers

Users can directly customize trackers by adding custom fields (no programming necessary)
Ability to re-order tracker columns and hide system default columns
Ability to set data type (e.g., text vs. date) and style of custom columns (e.g., color)
Customize tab view to set workflow for single or multiple studies
Support to updating system picklist values throughout the application
Select from available trackers for Admin, portfolio, study, site, and subject tracking -- create and place new trackers in the application

Site Contracts and Payments

Define templates at study level for country and multi-site association
Supports multiple contracts per study and site
Contract details include currency, item fee, overhead, holdback and subject visit associations
Ability to manage partial, full, unscheduled and holdback payments
Transparency into visit progress, data progress and fees
Generate detailed invoices, view payment tracking history, and manage budgets with CTMS Finance Reports
Use automations for invoicing of subject visits based on common rules
Upload and manage documents associated with invoice activities
Copy contract details, export views

Electronic Visit Reports

User-defined templates at portfolio level for multi-study use
Author and reviewer workflow for drafting through approval directly in app
Document attachments for related essential docs and letters
Integrated action items, deviations and subject content with system views
In-application workflow notifications and email alerts
Performance metrics and CTMS reports for authoring and approval
Uses 21 Part 11 compliant e-signatures for author and approver and document attachments
EVR integration and sync with subject records, protocol deviations, action items views
Functionally validated with integration to eTMF, e-signature and open issue carry forward to next EVR.

Data Integrations

SimpleTrials integrates directly with EDC systems
EDC integration provides nightly downloads of subject enrollment, subject status, and subject visit dates among other possibilities
The user interface is available directly within the SimpleTrials application and includes the ability to select the vendor, complete the relevant fields (e.g. API key, trigger rules), perform test transfers, define data mapping and enable integration processing
Additional automations in SimpleTrials CTMS support processing of site payments, subject visit activities, data completion activities, and CTMS Reporting
Current EDC vendors with out-of-the-box integration include: Castor, ClinCapture, IBM CD, iMedNet, DSG, REDCap Cloud and Medrio. RAVE EDC and additional vendors to be added.

Ready for a comprehensive CTMS toolkit?

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Expert CTMS Support

All users receive customer support from our internal team of CTMS experts.
In application help tips guide you as you go.
Comprehensive user manuals and feature guides are available.
Online training videos are accessible to all users at any time.
Experienced professional services team members available to provide training and on-boarding assistance at additional cost.

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