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 a clinical trial management system focused on assisting sponsors, sites, CROs and other vendors with study and portfolio management. It is a web-based system to be accessed via browser or mobile device. SimpleTrials is subscription-based Software-as-a-Service, so we handle all the hosting and system management, monitoring and maintenance.
Does SimpleTrials include an eTMF?
Yes! The SimpleTrials eTMF is included as a core feature of our CTMS product. The eTMF is available for all subscription plans with no additional purchase necessary. SimpleTrials eTMF features include support for DIA reference models, our TMF model or a build-your-own model for study and site documents. Essential documents are defined, tracking features are available out-of-the box, and file uploads are available using 21 CFR Part 11 compliant electronic signatures. Additional features include: expiration date tracking, email and in-app alerts, multi-file upload, zipfile download, custom column/fields, document associations, search, CTMS reports and much more!
Does SimpleTrials include payments?
Yes! The SimpleTrials CTMS product includes site contract and payment functionality. Contracts can be defined for studies and countries and associated with sites. Payments within a given study can be managed with ease. System automations help teams set rules for full and partial payments based on common inputs. Contracts support subject based fees as well as fixed items as defined in investigator site agreements. Payments may be managed with flexibility using automations, integrations with EDC, data subject imports and internal workflows. Invoicing and payment tracking come standard. Well-designed features enable teams to manage individual study assessments, overhead, holdback, and supporting documentation. Exports and CTMS Reports facilitate fiscal management needs.
Does SimpleTrials include EDC (Electronic Data Capture) functionality?
As a CTMS & eTMF, SimpleTrials does not include EDC functionality; however, Trial By Fire Solutions has partnered with 12 + EDC organizations to support direct integration of EDC data into our CTMS products. EDC integrations with the SimpleTrials product supports the creation and updating of subject screening and enrollment records, subject visits and additional fields. As an on-demand product, the EDC user interface is available directly in the SimpleTrials product. The vendor-specific fields may be completed, EDC and CTMS fields directly mapped, record trigger rules defined, connectivity tested and integration go-live enabled.
I am looking for a CTMS. How can I evaluate SimpleTrials?
In order to keep our base subscription fees low, we take a streamlined approach to the sales process. We are transparent about our CTMS pricing and legal agreements, and we do not put a hard sell on any client. So you will likely find your experience with SimpleTrials different than our competitors, and we are proud of that. Here is what we suggest:
Sign up for a webinar to see SimpleTrials in action.
Review our standard legal agreements, since you will need to consent to those agreements when you subscribe.
Subscribe to a trial (evaluation) account. It only costs $49 for the month, and it gives you (5 users total) access to all premium features, and a sandbox study.
Let us know how we can help you! In order to keep base subscription fee low, we offer many optional premium services at additional cost. We recommend you elect a training session, and you might be interested in the validation packages and monthly dedicated client management support.
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 customers have access to our expert CTMS support team. The help desk is available from 9am to 8pm Eastern Time, Monday through Friday. We use a support request/ticket system to ensure that all requests receive a timely response and are resolved as quickly as possible. In addition, we offer the following:
Support Resources - all clients have access to SimpleTrials User Manuals, CTMS feature guides, training videos, and Compliance Portal.
Training - live online training, customized to our clients needs, is available at additional cost.
Client management - monthly check in calls, proactive CTMS workspace review, and ongoing CTMS guidance are available via our Professional Services team. This is an optional elective at additional cost.
Additional Professional services – the SimpleTrials team is available to support data integration efforts, customized support needs and validation/quality activities. These items are optional elective items at an additional cost.
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. SimpleTrials' cost for the first-year is likely to be between $1500 - $9,000 (considerably less than SimpleCTMS), depending on the size of your team and optional premium services you elect.
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 startup fees with SimpleTrials, and 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.