OpenClinica
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.
- Company typePrivate
- Founded2006
- HeadquartersWaltham, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
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.
OpenClinica firmographics
Firmographics- 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
OpenClinica industry classification
Industry- 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
Where OpenClinica is headquartered
LocationHeadquarters
- HQ city
- Waltham
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
OpenClinica business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure
Revenue model
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Subscription | Monthly | Launch - Self-serve EDC for independent researchers and lean teams |
| Subscription | Annual | Core - EDC + Reporting & Analytics for growing teams |
| Subscription | Annual | Advanced - Core Bundle + Add-on Module for complex multi-site studies |
| Subscription | Multi-year contract | Enterprise & Academic - All modules, unlimited studies for large organizations |
| Other | Pay-as-you-go | Professional Services |
| Subscription | Annual | CRO Partner Program |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels8 records
OpenClinica product offering
Product offeringCore 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
Companies that use OpenClinica
Customer profileNamed customers22 records
Segments3 records
Ideal customer profiles3 records
OpenClinica technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration4 records
AI capability4 records
Feature8 records
OpenClinica partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered flagship and strategic_acquisition.
- Endpoint StrategyflagshipEndpoint 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_acquisitionOpenClinica 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
OpenClinica competitors and assessment
Company assessmentDirect 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
OpenClinica social profiles
Digital presenceOpenClinica compliance and trust
Trust signalCompliance6 records
OpenClinica financial estimates
Financial estimateRevenue estimate
Valuation estimate
OpenClinica leadership team
Management profileNumber of profiles
Profiles3 records
OpenClinica subsidiaries and ownership
Company hierarchySubsidiaries1 record
OpenClinica funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
OpenClinica M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about OpenClinica
What does OpenClinica do?
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.
Is OpenClinica a public or private company?
OpenClinica is a private company. It is classified as private equity controlled and is currently operating.
When was OpenClinica founded?
OpenClinica was founded in 2006. It employs 11 to 50 people.
Where is OpenClinica based?
OpenClinica is headquartered in Waltham, United States, in the North America region.
How does OpenClinica make money?
Two revenue lines are on record. Subscription SaaS - Core Platform is the primary driver. The others are professional Services.
Who are OpenClinica's main competitors?
Direct peers on record are Medrio, Castor and Formedix. Broad incumbents are Veeva Systems, Medidata Solutions (Dassault Systèmes), Oracle Health Sciences (Clinical One), Clario and Signant Health. Emerging players are REDCap (Vanderbilt) and YPrime.
Does OpenClinica have an API?
Yes. OpenClinica provides an advanced web services API that enables real-time data interchange with external systems including labs, IWRS, CTMS, and payment systems. API access is included with Core and Advanced subscription tiers, providing full access to workflows, SMS, and API capabilities. Developer documentation is at docs.openclinica.com/oc4/how-and-when-to-use-apis.
What industry is OpenClinica in?
OpenClinica's product category is Clinical Trial Software (eClinical / EDC). Its primary akta.pro industry code is HLACAOAA, Electronic Data Capture (EDC) Platforms, with a secondary code of HLACAOAB, eCOA/ePRO/eDiary & Patient-Facing Data Collection. Its NAICS code is 513210 and its SIC code is 7372.