Tool profile
SimpleTrials: cost, fit and limits
SimpleTrials is a clinical trial management and eTMF product made by Trial By Fire Solutions in the United States for sponsors, CROs and research sites. It tracks studies, sites, contracts, payments and trial documents, and it prints monthly prices for several plan sizes.
What to know first
SimpleTrials is the plainest priced option in this category: Standard at $849 a month, Premium at $2,399, Premium Plus at $3,599, an eTMF-focused plan at $2,199 and a Premium for Sites plan at $599. A startup fee applies to each, annual billing takes 20 percent off, and add-ons such as EU data hosting and validation packages are priced. The pages describe no AI features, so it sets a non-AI baseline.
SimpleTrials at a glance
| Maker | Trial By Fire Solutions, United States |
|---|---|
| Free plan | Free trial only |
| Entry price | $849 per month for Standard |
| API access | Yes |
| Category | Best AI Clinical Trial Software in 2026, rank 7 of 11 |
| Website | simpletrials.com |
Who SimpleTrials is best for
Research sites
Premium for Sites at $599 a month covers core CTMS and eTMF with contracts and payments for up to 100 studies and 10 users.
Small sponsors with a few studies
Standard supports up to 10 studies and 5 users with core CTMS and eTMF and 10GB of storage, which suits an early-stage biotech.
Teams that need European hosting
An EU data hosting add-on at $349 a month is listed, which is rare on a price page in this category.
SimpleTrials plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| Standard | $849 per month | Up to 10 studies, 5 users (10 maximum), core CTMS and eTMF, 10GB storage and basic support. |
| Premium and Premium Plus | $2,399 and $3,599 per month | Premium adds contracts, payments, eVisit reports and 100GB. Plus adds forecasting, risk management, an eISF portal, API and premium support. |
| Premium eTMF | $2,199 per month | Focused on the trial master file with an eISF portal, QC workflow, reference models and API. CTMS features can be added later. |
| Premium for Sites | $599 per month | Up to 100 studies and 10 users with core CTMS and eTMF, contracts and payments, and 100GB storage. |
Checked November 2026.
What SimpleTrials does
- Contracts and payments
- Premium plans track site contracts and payments in the same record as visits and milestones, which suits sites that bill sponsors per visit. Tracking payments next to visits reduces end-of-month reconciliation work.
- eISF portal
- A portal for the electronic investigator site file sits in higher tiers and the eTMF plan, so sites and sponsors can share regulatory documents. Premium eTMF adds a QC workflow and reference models for filing consistency.
- Forecasting and risk management
- Premium Plus adds forecasting and risk management tools, aimed at sponsors that track enrollment against plan. Premium Plus also adds client management and API access for connecting to other systems and reporting tools.
- Custom trackers
- Teams can add trackers for $50 a month per tracker per study, which lets them follow items the standard fields do not cover. Custom trackers are useful for local requirements.
- Validation packages
- Validation packages start at $4,499, and an agile process with traced qualification tests and change control is described. The pages also describe documented requirements, recorded test evidence, risk analysis and formal change control.
How SimpleTrials handles your data
SimpleTrials describes itself as a US-based company with data retained in the United States, hosted in a qualified server environment at a data center holding SOC 1, 2 and 3, PCI DSS, ISO 27001 and ISO 9001 credentials. Full nightly backups go to geographically separate locations. The privacy page says data entered is used only to support the products and services, and it states that data is not sold or shared with advertisers. Retention periods are not stated, subprocessors are described in the Terms of Use, and AI is not mentioned.
Where SimpleTrials falls short in practice
- No AI described. The pages mention no AI features, so there is no extraction, coding or study-building help to evaluate. Teams that want automatic extraction, coding or protocol drafting have to look elsewhere.
- Startup fee is hidden. Every plan requires a startup fee whose amount is not listed, which makes the first-year cost unclear until a quote. Extra users and training also have separate charges.
- US data by default. Data is retained in the United States unless the EU hosting add-on is bought, which adds $349 a month. Compare the cost with vendors that state a region in the base price.
Works with
Alternatives to SimpleTrials
SimpleTrials: common questions
How much does SimpleTrials cost?
Plans run from $599 per month for Premium for Sites to $3,599 for Premium Plus, with Standard at $849. Annual billing takes 20 percent off, and a startup fee applies without a stated amount. Add-ons, such as EU hosting at $349 a month, cost more.
Is there a trial for SimpleTrials?
The pricing page lists a one-month trial with all Premium Plus features for up to ten users at $49. A free 30-day trial is also mentioned in an event listing on the home page, so confirm which terms apply before you start.
Does SimpleTrials offer European hosting?
Yes, as an add-on at $349 per month. By default the company states that data is retained in the United States in a data center holding SOC 1, 2 and 3, PCI DSS, ISO 27001 and ISO 9001 credentials. Confirm the region of backups too.
Does SimpleTrials include AI features?
No AI feature appears on the pricing, home or compliance pages we read. The product is described as a CTMS and eTMF toolkit, so AI extraction, coding or study-building help would need another vendor. It is a conventional CTMS and eTMF product that sells documented validation and priced plans.
What does SimpleTrials charge for extra users and validation?
The pricing page lists additional users at $375 per month per group of five, although its own example lists $250, so the figure may be out of date. Validation packages start at $4,499 and training is $700 per two-hour session.