Datatrak International

What Datatrak International does

Datatrak International, operating under the legal entity Fountayn, is a privately held enterprise SaaS provider of cloud-based eClinical software founded in 1991 in the United States and recognized as the first Electronic Data Capture (EDC) company. The company is headquartered in Austin, Texas (823 Congress Ave., Suite 150297), with operating geographies spanning the United States, European Union, and Japan, and a deployed footprint of 10,000+ studies across 83+ countries on six continents. Its platform unifies EDC, CTMS, eTMF, RTSM/IWRS, eConsent, ePRO/eCOA/eSource, Adjudication/Imaging, Local Lab Import, Post Market Surveillance, EMR/EHR integration, Trial Design services, and Data Management services into a single-database architecture, eliminating data silos and migrations that plague stitched-together point solutions.

The underlying technology is built around a single cloud database rather than acquired-and-integrated modules, with real-time data capture, AES-256 encryption at rest, TLS 1.3 in transit, SOC 2 Type II infrastructure, and validated compliance with FDA 21 CFR Part 11, HIPAA, GDPR, GCP (ICH E6(R2) and ICH E6(R3)), CDISC/CDASH, and PMDA-recognized methodology. Differentiated capabilities include eSource direct data entry, a Rapid Startup option for fast EDC deployment, just-in-time RTSM inventory optimization, and mid-study changes with zero downtime.

The business model is quote-based enterprise SaaS subscriptions billed annually, sold via direct field sales targeting pharmaceutical and biotechnology sponsors, CROs (Syneos Health, Precision for Medicine, ClinCloud), academic medical centers, medical-device companies (Stryker, Bausch & Lomb), and Japanese sponsors (Taisho Pharmaceutical, National Cancer Center Japan). Marquee customer logos include Pfizer, Roche, Novartis, Merck, Gilead Sciences, Sanofi, Amgen, AbbVie, Bayer, and Teva. The company is led by CEO and Chairman Alex Tabatabai (CEO since 2021, Chairman since 2026), VP of Product Patrick Smith, and QA Director Michael Raykhinshteyn (appointed 2026), and has not disclosed institutional funding, M&A, or revenue.

Name

Datatrak International

Legal name

Fountayn

Website

https://www.datatrak.com

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

251–500 employees

Short description

Datatrak International (legal entity Fountayn) is a privately held, US-based enterprise SaaS provider of a unified, single-database eClinical platform — EDC, CTMS, eTMF, RTSM, eConsent, and ePRO — serving pharmaceutical sponsors, biotechs, CROs, academic centers, and medical-device companies across 83+ countries.

Ownership category

akta.pro rank

Product category

Clinical Trial Software (eClinical Platform)

NAICS

Custom Computer Programming Services (541511), Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (518)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

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

akta.pro secondary industry

Electronic Data Capture (EDC) Platforms (HLACAOAA)

Keywords

• Electronic data capture
• Clinical trial management
• EClinical platform
• Randomization trial supply
• Electronic patient outcomes

Headquarters

HQ city

Cleveland

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, Marketing or Sales, Infrastructure, Operations

Revenue model

1. SaaS Subscription - eClinical Platform: Cloud-based software-as-a-service model providing access to integrated eClinical suite including EDC, CTMS, eTMF, RTSM, eConsent, ePRO modules. Customers pay subscription fees for platform access with different modules and configurations available.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Datatrak International, powered by Fountayn, provides a unified cloud-based eClinical platform combining Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), RTSM/IWRS, eConsent, ePRO/eCOA/eSource, adjudication and imaging modules, post-market surveillance, and EMR/EHR integration in a single database architecture. The platform is sold as a SaaS subscription to pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and academic institutions conducting FDA-regulated clinical trials.

Product overview

Datatrak International, powered by Fountayn, offers a unified cloud-based eClinical Technology Platform that combines all core clinical trial software products into a single database architecture. The platform comprises 12 integrated products: Electronic Data Capture (EDC) as the core system, Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), RTSM/IWRS for randomization and supply management, eConsent, ePRO/eCOA/eSource for patient-reported outcomes, Adjudication/Imaging/Data Import, Local Lab Import, Post Market Surveillance, EMR/EHR integration, and two service offerings (Trial Design and Data Management). Unlike integrated products from multiple vendors, all modules are designed to work together from inception, eliminating data silos and the need for migrations. Founded in 1991, the company has managed over 10,000 studies across 83+ countries.

Differentiator

Problem solved

Functional benefit

Products and services

• Local Lab Import Capability to import lab data from central or local labs directly into eCRFs with automated quality checks and PHI anonymization.
• Adjudication, Imaging, and Data Import Module for analyzing, anonymizing, and importing clinical imaging and data files in any format with automatic PHI protection and real-time quality checks.
• Electronic Data Capture (EDC) A cost-effective EDC/CDMS system that enhances data capture and cleaning with a Rapid Startup option, real-time visibility, edit checks, and audit trails for clinical trial teams collecting and managing clinical trial data.
• Clinical Trial Management System (CTMS) A fully integrated CTMS that manages clinical trials from startup to close, providing real-time visibility across all studies with support for study planning, site performance, site communications, and payments management.
• Electronic Trial Master File (eTMF) An integrated, compliant eTMF system that keeps trial documents organized, inspection-ready, and accessible from the EDC dashboard.
• RTSM/IWRS Randomization and Trial Supply Management system natively integrated with EDC for seamless, real-time control over randomization and clinical supply management, with support for just-in-time shipments and pre-stocked inventory approaches.
• eConsent Digital eConsent software built for decentralized and remote clinical trials that simplifies patient enrollment and informed consent processes with patient-friendly interfaces.
• ePRO/eCOA/eSource Electronic patient-reported outcomes and electronic clinical outcome assessment solution natively linked to EDC and RTSM, collecting patient data from any device with automated reminders and real-time availability to clinical staff.
• Post Market Surveillance Cloud-based pharmacovigilance software platform for conducting post-market surveillance and Phase IV studies with compliance-focused features.
• Trial Design Services Expert clinical trial design services supporting study protocol implementation and user training, helping clients build studies independently from requirements through testing and mid-study changes.
• Clinical Data Management Services Clinical data management team supporting data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

Quantifiable outcome

• 62% reduction in eTMF costs
• +3 more outcomes

Named customers23 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature6 records

Partnerships

One partnership is on record.

• Strategic Partner in JapancoreStrategic or Co-development PartnerFountayn developed a strategic partnership in Japan with expertise in the Fountayn platform and in-depth experience with PMDA regulatory requirements. This partnership provides in-country help desk support, eCRF translation services (including completion guidelines in Kanji), and local regulatory expertise for Japan-based clinical trial sites.

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Medidata Solutions (Dassault Systèmes): The dominant EDC/CTMS/eCOA platform (Rave, Rave EDC, eCOA) serving global pharma and CROs. Directly comparable to Datatrak as a unified eClinical suite targeting the same sponsor and CRO buyer base.
• Veeva Systems: Vault Clinical Suite (EDC, CTMS, eTMF, RTSM, ePRO) serves the same top-20 pharma customer base. Closest direct competitor on unified architecture and sponsor-led commercial model.
• Signant Health: Provider of eCOA, EDC, RTSM, and patient engagement solutions for clinical trials. Direct peer in ePRO/eCOA and trial logistics, serving similar pharma and CRO customers.
• Clario: Combines ERT and Bioclinica technology stacks to deliver EDC, eCOA, RTSM, imaging, and cardiac safety services. Comparable to Datatrak in eCOA/ePRO plus adjacent clinical trial endpoints.
• Advarra: Provider of eRegulatory, eTMF, IRB, and clinical technology solutions. Directly competes in eTMF and document management, overlapping with Datatrak's eTMF and compliance-heavy modules.
• Medrio: Cloud-native EDC and eClinical platform serving sponsors and CROs. Comparable as a mid-tier unified eClinical vendor, particularly for earlier-phase and academic trials.

Broad incumbents

• Oracle Clinical One: Oracle's unified clinical trial platform (Clinical One, including EDC, RTSM, ePRO) competing directly with Datatrak but with the R&D and capital backing of Oracle Health Sciences across a broader portfolio.
• Anju Software: Suite of clinical and life-science software (including EDC, CTMS, eTMF, safety). Broader eClinical portfolio with overlapping modules serving similar pharma, CRO, and academic customers.

Emerging players

• Castor: Cloud-based EDC and decentralized trial platform targeting academic and smaller sponsor trials. Emerging competitor with partial overlap in EDC, eConsent, and DCT use cases.
• OpenClinica: Open-source and cloud EDC/eClinical platform with comparable EDC, CTMS, and ePRO modules. Emerging niche competitor, particularly in academic and budget-sensitive segments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/DATATRAKinc
• Facebookfacebook.com/datatrakinc
• LinkedInlinkedin.com/company/datatrak-international

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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 International