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. 
 

Who is the Provider for SimpleTrials, and Where are You Located?

SimpleTrials is developed and supported by Trial By Fire Solutions, an eClinical software company based in Oakland, CA.  Trial By Fire Solutions was founded in 2008 based on their original product, SimpleCTMS.  Trial By Fire Solutions has many years of extensive CTMS experience 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 support team 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.  A user manual and in-app help are also available.
 

How is it Different from SimpleCTMS?

SimpleCTMS is our established CTMS application that has been on the market since 2010.  SimpleCTMS uses a single-tenant model (exclusive server and database for each customer) and each SimpleCTMS customer has a dedicated client manager for proactive support.  SimpleCTMS includes premium features like payments, electronic visit reports, and IRB/EC tracking. SimpleCTMS is well into the 5-figure range for the first year costs.  On the other hand, SimpleTrials is a multi-tenant system with customer support, but no dedicated client manager.  SimpleTrials does not initially have all the premium features that SimpleCTMS supports.  SimpleTrials cost for the first year is likely to be between $500 - $5,000 (considerably less than SimpleCTMS) for the first year, dependending on the size of your team).
 

SUBSCRIPTION & PRICING

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)?

Initially, SimpleTrials will be available to customers in the United States, Canada, Australia, New Zealand, Great Britain, Ireland and Western Europe.  We will be expanding to support additional countries in 2017.
 

How is payment handled?

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 any time time your card is charged.  Accepted credit cards: Visa, MasterCard, American Express, JCB, Discover, and Diners Club.
 

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).  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 $35 (the cost of our least expensive plan).  If you are evaluating CTMS solutions, we hope you will agree that $35 is well worth it (we have worked very hard on this system, and we think you will like it).  There is no long term obligation, and if you decide to stay on, you can upgrade your account as needed.
 

What is the subscription process?

  1. Choose a Plan here.
  2. Click Sign Up at the bottom to access the subscription page.
  3. If you need to review the legal documentation, see the link at the bottom of the form (or click here for the legal page).
  4. Submit the subscription page.
  5. Your subscription request will be reviewed by our team.  This should occur quickly if you subscribe during US business hours.
  6. 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.  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.
 

COMPLIANCE & DATA PROTECTION

Is SimpleTrials 21 CFR Part 11 Compliant?

SimpleTrials supports the features and controls needed for 21 Part 11 compliance, including user account controls, audit trail, archival policy (non-deletion) and electronic signatures.  SimpleTrials is hosted by a validated hosting provider. Achieving 21 Part 11 compliance requires a collaborative effort between customer and provider, and we are working on documentation to help facilitate this.
 

Where is SimpleTrials Hosted?

SimpleTrials is hosted by our trusted, validated hosting partner, ByteGrid, in their premier Silver Spring, MD data center.  The Silver Spring data center has achieved the following certifications: SOC 2 Type II, GSA ISC Level IV, PCI DSS, FISMA, ISO 27001, ISO 9001, EHNAC accredited, GxP & HIPAA Qualified.
 

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.  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.