SimpleTrials
SimpleTrials is a cloud-based CTMS and eTMF platform, operated by Trial By Fire Solutions, offering subscription-based clinical trial management for biotech and pharma sponsors, CROs, and clinical research sites.
- Company typePrivate
- Founded2008
- HeadquartersOakland, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What SimpleTrials does
SimpleTrials is a cloud-based Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) platform developed by Trial By Fire Solutions, LLC, a privately held company founded in Oakland, California in 2008. The company launched SimpleTrials in November 2016 as the first on-demand, subscription-based CTMS, combining CTMS and eTMF functionality in a single validated, 21 CFR Part 11 compliant package built by clinical trial professionals with over 20 years of domain experience. The platform serves three primary customer segments: biotechnology and pharmaceutical sponsors, contract research organizations (CROs), and clinical research sites, with a horizontal segmentation approach that addresses the full clinical trial operations workflow from site startup through closeout.
The core technology is a multi-tenant SaaS platform hosted on SOC 1/2/3, PCI DSS, ISO 27001, and ISO 9001 certified US data centers, with optional EU data hosting. Key capabilities include site and study tracking, document management with DIA reference model support, screening and enrollment tracking, subject visit calendars, protocol deviation tracking, site contracts and payments, electronic visit reports (EVR), risk-based monitoring with key risk indicators (KRIs), sponsor oversight dashboards, API access, and certified integrations with Viedoc EDC and AcceleTrial study startup. The platform is modularly designed with configurable trackers, custom workflows, and automated cross-module updates.
The business model is product-led growth with transparent, publicly disclosed pricing and self-serve online subscription. Plans range from a $49 trial to a $599/month Site plan, $849/month Standard, $2,199/month eTMF, $2,399/month Premium, and $3,599/month Premium Plus, with annual billing offering a 20% discount and custom enterprise pricing for larger organizations. Revenue is complemented by add-on services including EDC/IRT integration setup ($7,500 one-time), validation packages (starting at $4,499), training sessions, and per-tracker fees. The company is founder-led, with co-founders Jon Cecchettini (CTO) and Nancy Cecchettini (CPO) at the helm, and operates without disclosed external funding or venture capital.
SimpleTrials firmographics
Firmographics- Name
- SimpleTrials
- Legal name
- Trial By Fire Solutions, LLC
- Website
- https://simpletrials.com
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- SimpleTrials is a cloud-based CTMS and eTMF platform, operated by Trial By Fire Solutions, offering subscription-based clinical trial management for biotech and pharma sponsors, CROs, and clinical research sites.
- Ownership category
- akta.pro rank
SimpleTrials industry classification
Industry- Product category
- Clinical Trial Management Software
- NAICS
- Custom Computer Programming Services (541511)
- SIC
- Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- eTMF & Trial Document Management (HLACAOAF)
Keywords
Where SimpleTrials is headquartered
LocationHeadquarters
- HQ city
- Oakland
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
SimpleTrials business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Infrastructure, Marketing or Sales, Operations
Revenue model
- Subscription Revenue: Monthly and annual subscription fees for CTMS and eTMF access. Plans range from $599/month for sites to $3,599/month for premium plus tier. Annual subscriptions receive 20% discount. Revenue generated through tiered subscription model based on number of users and studies.
- Add-on Services: Additional revenue from optional services including EDC/IRT integration support ($250/month per study), EDC/IRT integration setup ($7,500 one-time), EU data hosting ($349/month), custom trackers ($50/month per tracker per study), training sessions ($700 per 2-hour session), and validation packages (starting at $4,499).
- User Add-ons: Additional user account packages available in groups of 5 users at $375/month. Enterprise pricing with custom quotes for larger organizations requiring vendor qualification support and invoicing options.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Monthly | Standard Plan - $849/month |
| Subscription | Monthly | Premium Plan - $2,399/month |
| Subscription | Monthly | Premium Plus Plan - $3,599/month |
| Subscription | Monthly | eTMF Plan - $2,199/month |
| Subscription | Monthly | Sites Plan - $599/month |
| Subscription | Multi-year contract | Enterprise - Custom pricing |
| Subscription | Pay-as-you-go | Trial Plan - $49 |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
SimpleTrials product offering
Product offeringCore offering
SimpleTrials is an on-demand, subscription-based Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) platform for clinical trial sponsors, Contract Research Organizations (CROs), and investigative sites. The platform delivers end-to-end study management including site tracking, document management, subject visit calendars, screening and enrollment tracking, protocol deviations, action items, study milestones with Gantt charts, reports and dashboards, electronic visit reports (EVR), site contracts and payments, custom trackers, and EDC integration, all within a single validated 21 CFR Part 11 compliant package.
Product overview
SimpleTrials is a cloud-based Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) platform offered as an on-demand subscription service by Trial By Fire Solutions. The platform is delivered as a unified CTMS & eTMF toolkit with multiple subscription tiers: Standard Plan ($849/month), Premium Plan ($2,399/month), Premium Plus Plan ($3,599/month), eTMF-focused plan ($2,199/month), Site Plan ($599/month), Enterprise (custom pricing), and a Trial Plan ($49). All plans include core CTMS and eTMF functionality such as site tracking, document management, subject visits, calendars, and compliance tools. Premium tiers add Electronic Visit Reports (EVR), Site Contracts and Payments, custom trackers, and API access. The platform is notable as the industry's first on-demand subscription-based CTMS, launched in November 2016, with plans starting at $599/month for sites and $849/month for standard plans.
Differentiator
Problem solved
Functional benefit
Products and services
- SimpleTrials CTMS Cloud-based Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) solution offered as an on-demand subscription for sponsors, CROs, and sites. Provides end-to-end study management including site tracking, document management, subject visits, calendars, payments, and compliance tools.
- SimpleTrials eTMF (Standalone Plan) Standalone Electronic Trial Master File offering for organizations with TMF-specific needs. Includes all eTMF features, eISF Portal, reference models, QC workflow, email inbox, and API support, with CTMS features available to be added at any time.
- Viedoc Verified Partner Integration Certified CTMS-EDC integration between SimpleTrials and Viedoc's Electronic Data Capture platform, enabling automated data flow for enrollment, visits, deviations, KRIs, and financial tracking with real-time data exchange and pre-built connectors.
- Risk-Based Monitoring and Sponsor Oversight Risk-based monitoring module with configurable Key Risk Indicators (KRIs) for site startup, screening and enrollment, deviations, and monitoring activities, paired with Sponsor Oversight tooling that provides real-time visibility into trial progress at site, country, or study level for outsourced study management.
Quantifiable outcome
- 85% year-over-year growth in 2023 with significant customer growth across EU and APAC regions
- +2 more outcomes
Companies that use SimpleTrials
Customer profileNamed customers17 records
Segments4 records
Ideal customer profiles4 records
SimpleTrials technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
Feature11 records
SimpleTrials partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- ViedoccoreSimpleTrials joined Viedoc's Verified Partner Program in August 2025. The integration enables automated data flow between SimpleTrials CTMS and Viedoc EDC across enrollment, visits, deviations, KRIs, and financial tracking. This verified partnership certifies trusted clinical technology integration with pre-built connectors and seamless interoperability.
- LINEA System (AcceleTrial)corePartnership between LINEA System, LLC and Trial By Fire Solutions to offer AcceleTrial and SimpleTrials as a fully integrated solution. AcceleTrial's Study Start-up Management System (SSMS) provides access to a global database of over 100,000 ranked investigators and sites with automated workflow. Integration allows sponsors to leverage AcceleTrial for site selection and SimpleTrials for end-to-end study management including eTMF, electronic visit reports, and site payments.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
SimpleTrials competitors and assessment
Company assessmentEmerging players
- CRIO: CRIO provides an eClinical platform focused on clinical research sites, including eSource, eRegulatory, and CTMS modules. Emerging player with significant overlap to SimpleTrials' site-focused plan and SMB pricing model.
- Castor: Castor is an eClinical platform offering EDC, ePRO, and eConsent with growing CTMS-adjacent functionality. Comparable to SimpleTrials in targeting SMB and mid-market sponsors with cloud-first, subscription-based clinical trial software.
Broad incumbents
- Veeva Systems: Veeva is the dominant cloud software provider for life sciences, offering a CTMS within its Veeva Clinical Platform suite. It competes with SimpleTrials for sponsor-side CTMS deals but at the enterprise tier and with a much broader product portfolio.
- Oracle Clinical One: Oracle's Clinical One platform includes a CTMS targeting large pharma sponsors. It is a major incumbent in the eClinical space and competes for the same clinical trial management workloads as SimpleTrials, though at enterprise scale.
- Medidata (Dassault Systèmes): Medidata offers the Rave CTMS as part of its broader eClinical platform used by most large sponsors. Overlaps with SimpleTrials on CTMS functionality and target end users (sponsors and CROs), but with significantly broader scope and scale.
- IQVIA Technologies: IQVIA offers CTMS through its eClinical and suite of clinical technology solutions alongside its CRO services. Competes with SimpleTrials for sponsor CTMS procurement, predominantly at the enterprise tier.
Direct peers
- Bio-Optronics: Bio-Optronics provides Clinical Conductor CTMS, a longstanding sponsor- and site-focused CTMS. Directly competes with SimpleTrials in the trial management workflow for sites and mid-sized sponsors, with comparable feature set and pricing tier.
- Advarra CTMS: Advarra offers a CTMS solution widely used by academic medical centers, sponsors, and CROs. Directly comparable to SimpleTrials in target customers and feature set, with a similar mid-market and site-segment focus.
- Florence eBinders: Florence provides eTMF and eISF solutions for sponsors, CROs, and sites with a focus on investigator site file management. Most directly comparable to SimpleTrials' eTMF Plan and eISF portal offerings.
- RealTime Software Solutions: RealTime offers site- and sponsor-focused CTMS and eRegulatory solutions for clinical research sites. Closely comparable to SimpleTrials' Sites Plan and a direct competitor in the under-$1k/month clinical site segment.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
SimpleTrials social profiles
Digital presenceSimpleTrials compliance and trust
Trust signalCompliance8 records
SimpleTrials financial estimates
Financial estimateRevenue estimate
Valuation estimate
SimpleTrials leadership team
Management profileNumber of profiles
Profiles2 records
SimpleTrials funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SimpleTrials M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SimpleTrials
What does SimpleTrials do?
SimpleTrials is an on-demand, subscription-based Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) platform for clinical trial sponsors, Contract Research Organizations (CROs), and investigative sites. The platform delivers end-to-end study management including site tracking, document management, subject visit calendars, screening and enrollment tracking, protocol deviations, action items, study milestones with Gantt charts, reports and dashboards, electronic visit reports (EVR), site contracts and payments, custom trackers, and EDC integration, all within a single validated 21 CFR Part 11 compliant package.
Is SimpleTrials a public or private company?
SimpleTrials is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was SimpleTrials founded?
SimpleTrials was founded in 2008. It employs 11 to 50 people.
Where is SimpleTrials based?
SimpleTrials is headquartered in Oakland, United States, in the North America region.
How does SimpleTrials make money?
Three revenue lines are on record. Subscription Revenue is the primary driver. The others are add-on Services and user Add-ons.
Who are SimpleTrials's main competitors?
Emerging players on record are CRIO and Castor. Broad incumbents are Veeva Systems, Oracle Clinical One, Medidata (Dassault Systèmes) and IQVIA Technologies. Direct peers are Bio-Optronics, Advarra CTMS, Florence eBinders and RealTime Software Solutions.
Does SimpleTrials have an API?
Yes. API support is included in the Premium Plus plan. The API enables data exchange capabilities including data imports and integrations at portfolio and study level (e.g., Sites, Contacts, Startup, Subjects, Action Items). EDC/IRT integration setup is available as a paid add-on service.
What industry is SimpleTrials in?
SimpleTrials's product category is Clinical Trial Management Software. Its primary akta.pro industry code is HLACAOAF, eTMF & Trial Document Management. Its NAICS code is 541511 and its SIC code is 7370.