OpenClinica

What OpenClinica does

OpenClinica (OpenClinica, LLC) is a commercial open-source clinical trial software company headquartered in Needham, Massachusetts, providing a unified eClinical platform for Electronic Data Capture (EDC), eConsent, eCOA/ePRO, Randomization, EHR-to-EDC integration (Unite), Reporting & Analytics, and patient recruitment (Recruit). The platform is built on industry interoperability standards (FHIR, HL7) and integrates with Epic and Cerner EHRs across 450+ clinical trial sites. The company has operated for over 20 years, launching 10,000+ studies and supporting 1,500+ clients across 100+ countries with regulatory-grade compliance (SOC 2 Type II, ISO 27001, 21 CFR Part 11, HIPAA, GDPR, ICH GCP E6 R2).

The platform is modular and is sold to three primary customer segments: small-to-midsize sponsors in pharma, biotech, and medtech; academic medical centers running investigator-initiated research; and contract research organizations (CROs) running multi-sponsor studies. Acquired in December 2024, subsidiary BuildClinical provides digital recruitment capabilities integrated into the Recruit module. OpenClinica Share (launched November 2024) is a participant-facing mobile app for secure health-record sharing. Revenue is generated through tiered SaaS subscriptions (Launch $750/month, Core $3,000/month, Advanced $3,750/month, Enterprise/Academic custom), à la carte add-on modules, and professional services ($275-$350/hour), with a self-serve motion for the Launch tier and a sales-led motion for higher tiers.

Growth capital was provided by Thompson Street Capital Partners in a February 2023 PE growth investment. The company is led by CEO David Kay (appointed May 2025) and Chief Commercial Officer Andy Ferrin (appointed January 2026 from Medrio). In January 2026 OpenClinica launched a CRO Partner Program, with Endpoint Strategy as inaugural partner, to extend distribution through CROs serving mid-market and MedTech clients. Headcount is reported at 11-50 employees.

Name

OpenClinica

Legal name

OpenClinica, LLC

Website

https://openclinica.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

OpenClinica provides a unified eClinical platform (EDC, eConsent, eCOA, Randomization, EHR-to-EDC, analytics, and Recruit) for small-to-midsize pharma, biotech, medtech sponsors, academic medical centers, and CROs running clinical trials across 100+ countries.

Ownership category

akta.pro rank

Product category

Clinical Trial Software (eClinical / EDC)

NAICS

Software Publishers (513210), Software Publishers (5132)

SIC

Services-Prepackaged Software (7372), Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Electronic Data Capture (EDC) Platforms (HLACAOAA)

akta.pro secondary industry

eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB)

Keywords

• Clinical trial software
• Electronic data capture
• EClinical platform
• Patient recruitment
• Clinical data management

Headquarters

HQ city

Waltham

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Subscription SaaS - Core Platform: Recurring subscription revenue from modular eClinical platform licenses. Customers pay based on selected tier (Launch, Core, Advanced) with add-on modules. Multi-study discounts and multi-year commitments available. Professional services (consulting, training, engineering) offered as add-on.
2. Professional Services: Consulting at $275/hr for workflow optimization, CRF design, study build planning. Training at $300/hr for instructor-led sessions. Engineering at $350/hr for randomization setup, integrations, custom workflows, API configuration, and migration. Volume packages available for 25+, 50+, or 100+ hour bundles.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels8 records

Core offering

OpenClinica sells a cloud-based SaaS eClinical platform centered on Electronic Data Capture (EDC), with modular add-ons including eConsent, eCOA, Randomization, EHR-to-EDC integration, Reporting & Analytics, and patient recruitment (Recruit). Customers are clinical research sponsors, CROs, and academic medical centers running regulated clinical trials and patient registries. The platform is sold as tiered subscriptions (Launch, Core, Advanced, Enterprise/Academic) plus optional professional services.

Product overview

OpenClinica offers a unified eClinical platform that combines multiple clinical trial solutions into an integrated architecture. The core platform centers on Electronic Data Capture (EDC), which serves as the foundational system for data collection. Additional modules including eConsent, eCOA (Electronic Clinical Outcome Assessment), Randomization, EHR-to-EDC integration, Reporting & Analytics, and Recruit (patient recruitment) are available as add-on modules that connect to the core EDC. The platform also includes OpenClinica Code for integrated medical coding and OpenClinica Participate for participant-facing ePRO functionality. OpenClinica Share enables participant health record sharing via mobile app. BuildClinical (acquired December 2024) provides digital recruitment capabilities. The modular architecture allows users to purchase only needed components while maintaining data integration across all modules. Built for small-to-midsize sponsors, CROs, and academic teams with 20+ years of operation supporting 1,500+ clients across 100+ countries.

Differentiator

Problem solved

Functional benefit

Brands

• OpenClinica Participate: Mobile app for electronic patient reported outcomes (ePRO) allowing participants to report outcomes directly from any device.
• OpenClinica Share
• Unite

Products and services

• EDC (Electronic Data Capture) Purpose-built electronic data capture and eCRF software providing 21 CFR Part 11 compliance, flexible study design, drag-and-drop form building, real-time edit checks, and dedicated support for clinical research teams running regulated trials.
• eConsent Multimedia-rich electronic informed consent solution with comprehension checks, automated notifications, and secure e-signatures supporting decentralized, hybrid, and in-person trial consent workflows for clinical research sponsors.
• eCOA (Electronic Clinical Outcome Assessment) Mobile-friendly electronic clinical outcome assessment and patient-reported outcome (ePRO) collection with automated reminders and flexible forms that increase compliance and reduce missing data, BYOD-compatible with no app installation required.
• Randomization Integrated randomization solution supporting simple, block, random permuted block, and minimization methods with stratification by any CRF variable, enabling real-time randomization directly within CRFs with complete audit trails.
• EHR-to-EDC (Unite) Standards-based (FHIR, HL7) integration that automates source data acquisition from patient EHRs (Epic, Cerner) directly into study databases, eliminating manual transcription with a 61% cost reduction and GCP/21 CFR Part 11 compliance.
• Reporting & Analytics Real-time clinical data visualization and analytics with pre-built reports for enrollment, queries, SDV, and adverse event tracking, including a point-and-click report builder and SQL access with automated alerts.
• Recruit (Patient Recruitment) Patient recruitment solution offering precision-targeted digital outreach, smart pre-screening, branded landing pages, and real-time funnel analytics, achieving 3-5x lower cost per conversion than traditional methods with full HIPAA/GDPR compliance.
• OpenClinica Share Mobile App Secure, participant-friendly mobile app enabling participants to share real-world and complex medical data directly with research teams for clinical research purposes.

Quantifiable outcome

• Studies launch in 2-3 weeks instead of 3-6 months
• +5 more outcomes

Named customers22 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability4 records

Feature8 records

Partnerships

Two partnerships are on record, tiered flagship and strategic_acquisition.

• Endpoint StrategyflagshipChannel Partner/ Reseller/ Distributor · 29 January 2026Endpoint Strategy is the inaugural member of OpenClinica's CRO Partner Program launched January 2026. The boutique clinical consulting firm receives wholesale pricing, dedicated training, and joint marketing resources to deliver OpenClinica's unified eClinical platform—including EDC, eCOA, eConsent, Randomization, EHR-to-EDC, Reporting & Analytics, and Recruit—to their MedTech and other clients. The partnership enables Endpoint Strategy to offer clients unified platform solutions with cost and time savings compared to fragmented alternatives.
• BuildClinical LLCstrategic_acquisitionStrategic or Co-development Partner · 1 December 2024OpenClinica LLC acquired BuildClinical LLC in December 2024 to enhance its patient recruitment capabilities. The acquisition integrates BuildClinical's digital recruitment and data-driven strategies into OpenClinica's platform, strengthening their Recruit solution with better patient targeting, virtual recruitment methods, and direct-to-patient channels for decentralized trials.

Scale indicators15 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Medrio: Direct competitor in cloud-based EDC for small-to-mid sponsors and CROs. Highly comparable product breadth, customer profile, and mid-market GTM; notably, OpenClinica's new CCO Andy Ferrin previously led sales at Medrio.
• Castor: Cloud EDC and ePRO platform targeting academic and commercial sponsors with a self-serve orientation and modular pricing model directly comparable to OpenClinica's.
• Formedix: Clinical trial design and EDC/CDISC-focused platform with strong metadata-driven study build. Closely comparable in mid-market sponsor focus and protocol-to-EDC workflow.

Broad incumbents

• Veeva Systems: Enterprise incumbent with Vault CDB (EDC), Vault CTMS, Vault ePRO and broader clinical suite. Competes with OpenClinica in larger sponsors and CROs; bundled enterprise deals are a key competitive threat.
• Medidata Solutions (Dassault Systèmes): Industry-leading Rave EDC plus RTSM, eCOA, and imaging suite within the Dassault 3DEXPERIENCE platform. Largest commercial eClinical incumbent competing head-to-head with OpenClinica at the upper end of the mid-market and into enterprise.
• Oracle Health Sciences (Clinical One): Oracle's unified Clinical One platform offers EDC, RTSM, ePRO, and trial design as an integrated suite. Competes across sponsor and CRO segments with deep enterprise reach and bundled pricing.
• Clario: Broad clinical trial technology and endpoint services provider spanning EDC, eCOA, imaging, and wearables. Competes with OpenClinica in eCOA and the integrated clinical workflow space.
• Signant Health: Clinical technology provider covering eCOA, eConsent, patient engagement, and rater training. Overlaps with OpenClinica's eCOA and eConsent modules and competes in mid-to-large sponsor trials.

Emerging players

• REDCap (Vanderbilt): Free, open-source EDC widely used by academic medical centers. Competes with OpenClinica's Launch tier and academic pricing, anchoring the budget-sensitive end of the market.
• YPrime: eCOA, IRT, and clinical supply chain technology provider; overlaps with OpenClinica's eCOA and Randomization modules and competes for mid-market sponsor and CRO buyers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/OpenClinica
• LinkedInlinkedin.com/company/2294775
• Xx.com/OpenClinica
• Facebookfacebook.com/openclinica

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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

M&A1 record

Investments

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

Frequently asked questions about OpenClinica