SimpleTrials’ versatile CTMS puts well designed tools at hand, even on mobile devices. Have questions about how to find the right fit, right now? Let us help.
General Questions
What Is SimpleTrials?
SimpleTrials is an affordable, cloud-based Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) designed to help biotech and pharmaceutical sponsors, clinical research sites, CROs, and vendors in managing their studies and portfolios. Built with ease of use in mind, SimpleTrials enables teams to streamline clinical trial operations, track milestones and tasks, monitor site performance, and manage essential study documents—all from a single, easy-to-use platform. Accessible via any web browser or mobile device, it offers real-time visibility and collaboration for dispersed research teams worldwide.
As a subscription-based Software-as-a-Service (SaaS) CTMS and eTMF, SimpleTrials handles all secure hosting, system monitoring, upgrades, and ongoing maintenance—eliminating the need for costly IT infrastructure or internal system management. Our platform ensures compliance with industry regulations while offering flexibility to grow with your research needs. Whether you're managing a single study or a whole portfolio of trials, SimpleTrials provides the tools, reporting, and integrations needed to conduct efficient, compliant, and cost-effective clinical trials.
Does SimpleTrials include an eTMF?
Yes! The SimpleTrials electronic Trial Master File (eTMF) is included as a core feature of our Clinical Trial Management System (CTMS)—available in all subscription plans with no additional purchase required.
In addition, SimpleTrials now offers the eTMF as a standalone subscription plan, providing the same powerful functionality for sponsors, CROs, and research sites who may not need a full CTMS but still require a modern, compliant, and inspection-ready eTMF solution.
The eTMF offers flexible configuration options, including the CDISC Reference Model, DIA Reference Model, the proprietary SimpleTrials Reference Model, or a fully Build-Your-Own Model tailored to your study and site documentation needs.
The SimpleTrials eTMF enables teams to maintain complete, inspection-ready trial documentation. Essential documents are predefined, and tracking features come standard to help meet regulatory requirements with ease. Users can upload files with 21 CFR Part 11–compliant electronic signatures and take advantage of advanced document management tools such as expiration date tracking, email and in-app alerts, multi-file uploads, bulk zipfile downloads, custom columns and fields, document associations, and powerful search capabilities.
Our newest enhancement—Smart File Upload—takes efficiency to the next level by automatically recognizing, categorizing, and mapping uploaded files to the correct TMF location based on predefined rules. This automation reduces manual document sorting, improves filing accuracy, and speeds up document processing. Integrated CTMS reporting provides real-time visibility across all studies, ensuring efficient document handling, regulatory compliance, and audit readiness from start to finish.
Does SimpleTrials include payments?
Yes! The SimpleTrials Clinical Trial Management System (CTMS) offers robust site contract management and payment features to help sponsors, CROs, and research sites simplify clinical trial financial processes. Contracts can be created for each study and country, then directly linked to sites for smooth oversight. Payments within a study can be easily calculated, scheduled, and processed using built-in automation that allows teams to set rules for full or partial payments based on common inputs and milestones.
Contracts in SimpleTrials support both subject-based fees and fixed-cost items as outlined in investigator site agreements. Payment management is highly flexible, with options for automation, EDC integration, subject data imports, and internal workflows. Invoicing and payment tracking are included as standard features, ensuring transparency and efficiency throughout the payment cycle. Advanced tools allow teams to manage study assessments, overhead, holdback, and supporting documentation with ease. Robust exports and CTMS reports provide the fiscal oversight needed for compliance, budgeting, and financial reporting—helping you manage payments accurately and efficiently across all your clinical trials.
Does SimpleTrials include EDC (Electronic Data Capture) functionality?
SimpleTrials has partnered with 20+ leading EDC vendors to provide seamless, direct integration of EDC data into the SimpleTrials CTMS. These integrations support the creation and updating of subject screening and enrollment records, subject visit data, and other critical study fields—helping sponsors, CROs, and research sites maintain accurate, real-time data across platforms.
SimpleTrials EDC integration process allows vendor-specific fields to be completed, EDC and CTMS fields to be directly mapped, record trigger rules to be defined, connectivity tested, and integration go-live enabled—all from within the SimpleTrials platform. As an on-demand CTMS and eTMF solution, the EDC user interface is available directly in SimpleTrials for a smooth, unified workflow.
Examples of Supported EDC Vendors
Medrio EDC
Viedoc EDC
Mednet EDC
REDCap Cloud
OpenClinica EDC
Castor EDC
ClinCapture EDC
Medidata Rave
Veeva
Merative Zelta
By integrating with these and other top Electronic Data Capture systems, SimpleTrials enables research teams to streamline clinical operations, reduce data entry duplication, and improve data quality across studies.
I am looking for a CTMS. How can I evaluate SimpleTrials?
If you're seeking a budget-friendly, comprehensive Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF), choosing SimpleTrials is straightforward, transparent, and economical. Unlike many CTMS and eTMF providers, we streamline our sales process by keeping subscription fees low, avoiding aggressive sales tactics, and providing clear access to our pricing, legal terms, and features upfront. Our clients frequently mention that their experience with SimpleTrials stands out as refreshingly different from other CTMS and eTMF options—and we take pride in that.
Here’s how to get started evaluating SimpleTrials:
Sign up for a live Demonstration to see our CTMS and eTMF in action, explore the interface, and get your questions answered in real time.
Review our standardized Legal Agreements, which, unlike traditional eClinical vendor contracts, do not require a physical or digital signature. Instead, during the subscription process, you simply click "Agree To Terms" to proceed. This makes onboarding faster, easier, and more efficient.
Subscribe to a trial account for only $49 for 30 days. This trial grants access for up to 10 users, includes all Premium Plus CTMS and eTMF features, and provides a sandbox study to test workflows in a real-world setting.
Consider optional premium services—such as live training sessions, validation packages, and monthly dedicated client management support—to get the most from your evaluation and ensure your team’s success.
With SimpleTrials, you can evaluate a CTMS and eTMF solution designed for sponsors, CROs, and research sites without a long-term commitment. Our transparent pricing, affordable entry point, and flexible subscription options make it easy to determine if SimpleTrials is the right fit for your clinical trial operations.
Who Is the Provider for SimpleTrials, and Where Are You Located?
SimpleTrials is developed and supported by Trial By Fire Solutions, a CTMS-focused eClinical software company based in Oakland, CA, USA. Trial By Fire Solutions was founded in 2008 based on our original product, SimpleCTMS. Trial By Fire Solutions has many years of extensive, focused experience in the design and support of CTMS solutions, with a diverse, global base of CTMS users.
Do You Provide Customer Support?
Yes! All clients of SimpleTrials CTMS and eTMF have access to our expert clinical trial management support team. Our help desk is available Monday to Friday, from 9:00 AM to 8:00 PM Eastern Time. We use a structured support request and ticket system to provide prompt responses. Our aim is to address all inquiries swiftly, efficiently, and with minimal impact on your clinical trial activities.
In addition, SimpleTrials offers a variety of support and professional services to enhance your CTMS and eTMF experience:
Support Resources: All clients can access SimpleTrials user manuals, CTMS and eTMF feature guides, training videos, and our Compliance Portal to quickly answer questions and guide daily workflows.
Training: Live, online training sessions customized to your team’s needs are available as an optional service, helping users maximize CTMS and eTMF efficiency.
Client Management: Optional monthly check-ins, proactive user workspace reviews, and ongoing guidance are provided by our Professional Services team to ensure your operations run smoothly.
Additional Professional Services: Our team can support data integration efforts, customized support needs, and validation/quality activities. These services are elective and available at additional cost, providing flexibility to meet your organization’s specific requirements.
With dedicated CTMS and eTMF support, customized training, and optional professional services, SimpleTrials ensures that sponsors, CROs, and research sites can efficiently manage clinical trial studies, site workflows, and compliance requirements while reducing operational risk.
What does “On-Demand” mean?
Products and services that utilize an on-demand model like SimpleTrials are available in many industries. Although the Life Sciences Industry is supported by many eClinical products, not all are built to be managed directly by the customer based on their real-time needs. For SimpleTrials, “on-demand” means putting the customer in control of their CTMS. Here’s how:
Customers subscribe to the CTMS service when they are ready. The subscription process is fully automated through the website and the SimpleTrials team activates the customer workspace shortly after the subscription occurs.
We do not impose a ‘waiting period’ before customers can use the SimpleTrials product and services. Once the customer subscribes, user accounts can be created and the product is ready for use. No waiting for us to setup your server when you need to get to work.
All support materials including training videos, user guides and an example “Sandbox” study are always available to help your team learn and implement SimpleTrials. Reference what you need, when you need it.
Customers can change their subscription plan, add more user accounts, and purchase professional services such as training and EDC integration directly in SimpleTrials. Our professional services team will contact you to assist with the services you’ve elected. No run around to find the right person to work with or delays getting help when you need it.
Customers manage the SimpleTrials electronic payment mechanism directly within the application. Change from credit card to ACH payment (US customers) or update the frequency from monthly to annual. Set it and off you go.
Policies and Agreements that support the SimpleTrials service are always available on our website. Download when you’re ready. No long-term contract requirements. No contract surprises.
Validation, quality and compliance documentation are available directly in the SimpleTrials application. Access it when you need it.
Finally, since Customers can subscribe when they are ready, they can also cancel when they are ready directly within the application. Although we’re sorry to see you go, we realize things change and we don’t prevent you from cancelling or make it frustrating to end your time with us.
How is SimpleTrials CTMS Different from SimpleCTMS?
SimpleTrials is TBFS’s second CTMS product designed to be utilized by all types of Life Sciences Clients, including Sponsors, CROs, Sites, SMOs and AROs. The product is fully validated and built with an innovative on-demand model with scalability and customer configurations in mind. SimpleTrials is offered as a multi-tenant system which includes user support and extensive ‘self-serve’ training materials. The standard model comes with a built-in eTMF and extensive core features; the premium model is built for use by customers that need additional features for their established business needs. The TBFS Professional Services team can provide additional services such as client training and EDC integration assistance while optional premium services such as validation documentation are available for an additional fee. In order to keep the pricing affordable to all, SimpleTrials does not include start-up fees nor long term contractual commitments.
SimpleCTMS is our initial, established CTMS application that has been on the market since 2010 for Sponsors and CROs (e.g. not designed for Sites, SMOs and AROs). SimpleCTMS uses a single-tenant model (exclusive server and database for each customer) and each SimpleCTMS customer has a dedicated client manager. Due to this dedicated model, there are startup fees, minimum contract duration, and the overall cost is significantly higher than the SimpleTrials service. Unlike SimpleTrials, TBFS no longer supports optional validation services for the SimpleCTMS product. SimpleCTMS is well into the five-figure range for the first year costs which makes the SimpleTrials model a more affordable model for smaller more price sensitive clients in the Life Sciences Industry.
Subscription & Pricing
How much does SimpleTrials cost?
That is an easy one. We are proud to be the only CTMS provider who publishes pricing and allows customers to subscribe directly via the website. There are no long-term agreements (unless you want to prepay for an annual plan to receive the 20% discount). View the pricing page.
How do I get an account?
SimpleTrials subscriptions are based on an organization/company. The subscribing user signs up on behalf of the organization (typically their employer/company), and once approved, that user gains access to a CTMS "workspace" where they can setup studies and invite additional users to access the system.
Where is SimpleTrials available (what countries)?
SimpleTrials is currently available to clinical organizations in limited countries within North America, Australia, Europe, South America and Asia. We are continually expanding to support additional countries, as well as adding multi-language support. If your country is not found on the subscription page, please contact us.
How is payment handled?
In order to keep subscription fees low, we require electronic payment for all customers. A credit card number must be provided via the secure Subscription form. Once your subscription is approved, your card is charged for the amount of the plan you selected, and you are sent an email to activate your account and access the system. Your account will be automatically renewed and charged each month or year (based on your plan), until you close your account. Payment is charged at the beginning of the billing cycle, and your account automatically renews each cycle (monthly or annually). You will receive an email receipt any time your card is charged. Electronic payment via bank account (ACH) is also available for customers with a US-dollar based bank account. This option can be elected on the Subscription & Settings page within the application, and it takes a couple of days to setup due to the verification involved. Note that electronic payment by ACH for US-dollar bank accounts may only be established for active customers, not specified at the time of the initial subscription.
How long does it take to subscribe?
You can subscribe and start using the system in the same day. The subscription form only takes a minute, but you may want to take some time to review the legal agreements (master subscription agreement, terms of use and privacy policy) before subscribing. You can preview those documents here.
Do you offer free trial accounts?
We do not offer free trials, but you can test drive the system for one month for only $49 (the cost of our least expensive plan). If you are evaluating CTMS solutions, we hope you will agree that $49 is well worth it (we have worked very hard on this system, and we think you will like it). Trial Plan customers have access to all training videos and materials, a full-featured example “Sandbox” study, a custom tracker and additional Professional Services to support your SimpleTrials evaluation. There is no long term obligation, and if you decide to stay on, you can upgrade your account as needed. Trial plan data and files will automatically be available in your upgraded plan.
What is the subscription process?
Choose a Plan here.
Click Sign Up at the bottom to access the subscription page.
If you need to review the legal documentation, see the link at the bottom of the form (or click here for the legal page).
Submit the subscription page.
Your subscription request will be reviewed by our team. This should occur quickly if you subscribe during US business hours.
Once your account is approved, your card is charged and you will receive an email to setup your account and access the system.
How do I cancel/close my account? - Do you offer prorated refunds?
Customers can cancel their account at any time directly in the Admin area of SimpleTrials. The only obligation is for the current billing cycle that is already paid (e.g. 1 month). No prorated refunds are given (that keeps the accounting simple for us, and helps keep the overall prices down for you). So when you cancel, you have the ability to continue using the system until the end of your currently paid billing cycle. At the end of that cycle, your account will be closed and you will not be charged further. More detail is provided in the Master Subscription Agreement and the User Guide within the SimpleTrials application.
Compliance & Data Protection
Is SimpleTrials Validated?
Yes - the SimpleTrials application has been fully validated with the oversight of an independent, 3rd party compliance consultancy. Additionally, formal qualifications of the data center and platform provider were performed by external compliance consultants. With quarterly software updates including enhancements and fixes, SimpleTrials is maintained in a validated state via a documented change control program. All subscribers to SimpleTrials have access to the Compliance Portal view within the CTMS, which includes some compliance documentation that is available to all clients. Validation documentation is available optionally as an additional purchase.
Is SimpleTrials 21 CFR Part 11 Compliant?
Yes - SimpleTrials supports the features and controls needed for 21 CFR Part 11 compliance. The SimpleTrials validation activities include verification of 21 CFR Part 11 elements including system access restrictions, user account controls, audit trail, archival policy (non-deletion) and electronic signatures. Of note, achieving 21 CFR Part 11 compliance requires a collaborative effort between customer and provider (e.g. the customer has the necessary policies and procedures in place for the intended use of the application within their organization and the vendor has the necessary technical controls in place). The SimpleTrials validation packages contain additional 21 CFR Part 11 documentation including a checklist to help facilitate.
What is the SimpleTrials Technology Platform?
SimpleTrials is developed and hosted on a proven web application technology stack. SimpleTrials runs on a secure linux-based server platform with a relational database. System backups are taken nightly and backups are stored in geographically redundant locations. Encryption is used extensively to keep your data secure. The SimpleTrials user interface (client) uses pure web-based technologies, so users do not need to download any applications or plugins. We support multiple browsers across multiple platforms. Google Chrome is the recommended browser.
Is there a Quality System for SimpleTrials?
Yes. We have many years of experience developing and supporting validated and 21 CFR Part 11 compliant eClinical solutions. From the ground up, SimpleTrials was developed using a Quality System that includes best practices for GxP validated computer systems. This includes a Software Development Life Cycle where requirements, design and test cases are defined. Requirements are qualified via traceability matrices and objective evidence is collected to support test results.