Datatrak

What Datatrak does

Datatrak, operating commercially as "Datatrak, powered by Fountayn," is a clinical trial software vendor that provides a unified cloud-based eClinical platform combining Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), Randomization and Trial Supply Management (RTSM/IWRS), eConsent, ePRO/eCOA/eSource, imaging and lab import, post-market surveillance, and EMR/EHR integration in a single database architecture. Founded in 1991 as one of the first EDC companies and rebranded as Fountayn in 2021, the company has accumulated 10,000+ studies across 83+ countries and is validated against FDA 21 CFR Part 11, HIPAA, GDPR, GCP/ICH, CDISC/CDASH, and SOC 2 Type II standards.

The company monetizes primarily through SaaS subscriptions to the unified platform, with study-level pricing for individual modules (e.g., standalone eConsent in under four weeks) and quote-based pricing for full-suite deployments, complemented by professional services for trial design, implementation, validation, data management, and training. Go-to-market is enterprise sales-led, targeting pharmaceutical sponsors, biotechnology firms, contract research organizations (CROs), medical device companies, academic medical centers, and clinical trial sites, with named customers including Pfizer, Merck, Novartis, Roche, Sanofi, AbbVie, Amgen, Gilead, Bayer, Syneos Health, Stryker, Bausch and Lomb, and the National Cancer Center Japan. Distribution is direct (enterprise field sales plus inside sales for mid-market and academic buyers), with a consultant referral network extending reach.

Recent strategic activity (February-March 2026) includes a standalone eConsent module launch and a strategic equity investment and partnership with TAILRD Heart to integrate AI-powered cardiovascular analytics with Datatrak's clinical trial infrastructure. The company is small (51-100 employees), listed on OTC pink as DTRK, led by CEO and Chairman Alex Tabatabai, and headquartered in Austin, Texas.

Name

Datatrak

Legal name

Fountayn

Website

https://datatrak.com

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

51–100 employees

Short description

Datatrak (Fountayn) provides a unified cloud-based eClinical platform—EDC, CTMS, eTMF, RTSM, eConsent, ePRO, and more—for pharmaceutical sponsors, biotechs, CROs, medical device firms, and academic sites running global clinical trials.

Ownership category

akta.pro rank

Product category

Clinical Trial Software (eClinical Platform)

NAICS

Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (51821), Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372), Services-Computer Processing & Data Preparation (7374)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industry

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

Keywords

• Clinical trial software
• Electronic data capture
• EClinical platform
• Clinical trial management
• RTSM randomization systems

Headquarters

HQ city

Mansfield

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Unified eClinical Platform Subscription: SaaS subscription model providing access to integrated EDC, CTMS, eTMF, RTSM, eConsent, ePRO and other clinical trial modules. Subscription typically includes implementation support, training, and ongoing customer service.
2. Module-Level Licensing: Flexible, study-level pricing allowing customers to purchase individual modules (such as standalone eConsent) without requiring bundled packages. Enables access to specific functionality without full platform commitment.
3. Professional Services: Implementation, validation, training, and consulting services supporting customers from startup through closeout. Includes Trial Design services, Data Management support, and in-country helpdesk support.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Datatrak (powered by Fountayn) provides a unified, cloud-based eClinical platform that combines Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), Randomization and Trial Supply Management (RTSM/IWRS), eConsent, ePRO/eCOA/eSource, and related modules into a single shared database. It is sold as a SaaS subscription to pharmaceutical sponsors, biotech firms, CROs, medical device companies, and academic institutions running clinical trials.

Product overview

Datatrak, powered by Fountayn, is a unified eClinical platform that combines Electronic Data Capture (EDC), Clinical Trial Management (CTMS), Electronic Trial Master File (eTMF), Randomization and Trial Supply Management (RTSM/IWRS), eConsent, ePRO/eCOA/eSource, imaging and data import, lab integration, post-market surveillance, and EMR/EHR connectivity into a single cloud-based platform with a shared database architecture. The platform is designed for clinical trials of any complexity and is offered as a comprehensive suite where all modules work together natively, rather than as disconnected point solutions.

Differentiator

Problem solved

Functional benefit

Products and services

• Fountayn Unified eClinical Platform Cloud-based unified eClinical platform combining EDC, CTMS, eTMF, RTSM, eConsent, ePRO and additional clinical trial modules on a single database architecture for sponsors, CROs, sites and academics.
• Electronic Data Capture (EDC) Electronic Data Capture system for clinical trials with a Rapid Startup option, easy setup, edit checks, audit trails, and support for any study type.
• Clinical Trial Management System (CTMS) CTMS module integrated with the EDC for real-time visibility across studies, with customizable forms, reports and exports for sponsors and CROs.
• Electronic Trial Master File (eTMF) Integrated eTMF module that keeps trial documents organized, inspection-ready, and accessible from the EDC dashboard, with a documented 62% cost reduction in document management.
• RTSM/IWRS (Randomization and Trial Supply Management) RTSM/IWRS module natively integrated with EDC for real-time randomization and supply chain control, with a hybrid just-in-time and pre-stocked shipment approach.
• Standalone eConsent Solution

Quantifiable outcome

• 62% cost reduction in eTMF document management compared to traditional systems
• +3 more outcomes

Named customers17 records

Segments7 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• TAILRD HeartcoreStrategic or Co-development Partner · 16 March 2026Strategic collaboration announced March 16, 2026 to advance AI-driven healthcare and life sciences clinical research in cardiovascular care. Datatrak is making a strategic investment in TAILRD to expand the reach of TAILRD's AI-powered cardiovascular analytics platform while enabling more efficient clinical trials and real-world evidence generation. The partnership combines AI, real-world data, and clinical trial infrastructure to accelerate evidence-based cardiovascular therapies.
• Japan Strategic Partner (PMDA-recognized)coreStrategic or Co-development PartnerLong-term strategic partnership in Japan with expertise in the Fountayn platform and in-depth experience with PMDA regulatory requirements. Provided eCRF completion guidelines in Kanji and local helpdesk support for clinical trials. The partnership approach was recognized and commended by PMDA during regulatory audit as the preferred methodology, requiring no additional revisions compared to competitor trials.

Scale indicators5 records

Recent moves6 records

Expansion highlights7 records

Peers

• Veeva Vault CDB:

Direct peers

• Veeva Systems: Veeva's Vault CTMS, Vault EDC, and Vault eTMF form a unified cloud clinical trial platform directly comparable to Datatrak/Fountayn. Veeva is the dominant large-cap competitor targeting the same top-20 pharma sponsors.
• Medidata Solutions (Dassault Systèmes): Medidata's Rave EDC, Rave CTMS, eTMF, RTSM, and eCOA constitute a unified eClinical suite competing head-to-head with Datatrak. Strong enterprise pharma presence and AI-augmented trial capabilities.
• Oracle Health Sciences: Oracle's Clinical One / InForm EDC and broader Life Sciences cloud target the same pharma/CRO/sponsor buyer as Datatrak with deep enterprise integration capabilities.
• Castor EDC: Castor offers a cloud EDC and eClinical platform with published, transparent pricing and self-serve onboarding, directly competing for the same mid-market, academic, and biotech customers Datatrak targets.
• Medrio: Medrio provides cloud EDC, eCOA, eConsent, and RTSM modules with rapid deployment models overlapping Datatrak's mid-market and academic positioning, particularly the new standalone eConsent offering.
• OpenClinica: OpenClinica provides EDC, ePRO, and clinical trial data management solutions targeting academic, government, and mid-market sponsors — a directly comparable niche player to Datatrak's academic/CRO segments.
• ArisGlobal: ArisGlobal's LifeSphere CTMS, eTMF, and RIM platform competes with Datatrak's trial management and document management modules, particularly for mid-to-large pharma accounts.
• Advarra (formerly Forte/Clinical Conductor): Advarra's OnCore CTMS and eClinical platform serve academic medical centers, sponsors, and CROs — directly overlapping Datatrak's academic and sponsor customer segments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/DATATRAKinc

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Datatrak