Clinical Data

What Clinical Data does

Clinical Data Inc, operating under the brand name Clindata Cloud, is a privately held US-domiciled company (founded 2011) that has built and commercially launched a regulatory-compliant, cloud-based clinical data management and analytics platform targeting the clinical trial lifecycle. The platform consolidates study data from multiple sources and investigative sites in real time and automatically generates submission-ready CDISC datasets (SEND, CDASH, SDTM, ADaM) and analytics throughout the life of a study, replacing the dominant industry practice of manual end-of-Phase-III data standardization. A natively integrated Risk Based Monitoring module analyzes both raw and CDISC-standardized data against FDA-approved Risk Monitoring Plans to support the FDA-recommended approach to clinical trial oversight.

The core technology stack combines a real-time data ingestion and consolidation layer, a CDISC conversion engine claimed to process one million records in twelve minutes, machine learning and pattern recognition algorithms for anomaly, outlier and fraud detection, and a drag-and-connect graphical mapping hub for sponsor-side configuration. The platform is positioned against FDA mandates (100% CDISC submission compliance) and FDA guidance (Risk Based Monitoring under 21 CFR Part 11), and the company lists HIPAA, ISO 27001, SOC 1/2 / SSAE 16 / ISAE 24, FIMSA, and PCI DSS as security and regulatory certifications. Offices are maintained in North Wales PA, St. Louis MO, Santa Clara CA, and Chennai, India.

The business model centers on enterprise SaaS subscriptions sold via direct field sales to Bio-Pharma and Medical Device sponsors, supplemented by a CRO channel program in which Contract Research Organizations deploy the platform enterprise-wide and resell it to their sponsor clients. The company also provides the platform at no cost to universities and non-profit research institutions. Implementation follows a proprietary Create-Configure-Run (CCR) Agile SDLC methodology that compresses study go-live to approximately ten days from mapping specification sign-off. The company reports no disclosed revenue, no institutional funding rounds, and a stated headcount band of 1–10.

Name

Clinical Data

Legal name

Clinical Data Inc

Website

https://clindatainc.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

Clinical Data Inc (Clindata Cloud) provides a regulatory-compliant cloud platform that consolidates clinical trial data from multiple sites in real time, auto-generates submission-ready CDISC datasets, and runs integrated Risk Based Monitoring for Bio-Pharma, Medical Device, and CRO customers.

Ownership category

akta.pro rank

Product category

Clinical Data Management Software

NAICS

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 industries

Electronic Data Capture (EDC) Platforms (HLACAOAA), Clinical Trial Management Systems (CTMS) (HLACAOAD), Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN)

Keywords

• Clinical data management
• Clinical trial analytics
• Pharma data platform
• Electronic data capture
• Clinical EDC software

Headquarters

HQ city

North Wales

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations

Revenue model

1. Cloud Platform/SaaS Subscription: Clindata Cloud is a cloud-based technology platform. The primary revenue model is subscription-based access to the platform for clinical data standardization and risk monitoring.
2. Professional Services: Structured implementation services using the CCR (Create-Configure-Run) methodology. Includes study setup, configuration, mapping specification creation, and system sign-off support.
3. Support Services: Free 9 AM - 5 PM support included. Extended support options available for sponsors who want assistance running the instance.
4. Enterprise CRO Platform Deployment: CROs deploy Clindata Cloud as enterprise-wide data standardization and risk management platform, providing expanded value-added services to their sponsor clients.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels2 records

Core offering

Clinical Data Inc provides a cloud-based clinical data management and analytics platform for bio-pharma and medical device companies. The platform supports clinical trial data capture, management, and reporting workflows. It is positioned as a SaaS offering targeting pharmaceutical sponsors, medical device manufacturers, and contract research organizations.

Product overview

Clinical Data offers Clindata Cloud as a single unified platform for clinical data standardization and risk-based monitoring. The platform consolidates study data from multiple data sources and sites, automatically generating CDISC-compliant submission-ready datasets and real-time analytics throughout the study lifecycle. The Risk Monitoring capability is an integrated feature of the Clindata Cloud platform, enabling FDA-recommended Risk Based Monitoring approach to reduce site monitoring costs by approximately 25%.

Differentiator

Problem solved

Functional benefit

Products and services

• Clindata Cloud Platform A cloud-based SaaS platform that supports clinical data capture, management, and analytics/reporting for clinical trials. It is designed for bio-pharmaceutical sponsors, medical device manufacturers, and contract research organizations conducting or supporting clinical research.

Quantifiable outcome

• 25% reduction in investigative site monitoring costs
• +4 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature10 records

Partnerships

Three partnerships are on record, tiered minor and core.

• Validation CROs and ConsultantsminorImplementation/ SI/ Consulting PartnerValidation CROs and consultants can benefit from the sophisticated risk management features of Clindata Cloud to provide enhanced services to their clients.
• Universities and Non-Profit Research InstitutesminorOthersClinical Data Inc provides Clindata Cloud for free to universities and non-profit research institutions to support their clinical investigations. This addresses budget constraints that research organizations face.
• CRO PartnerscoreChannel Partner/ Reseller/ DistributorCROs can deploy Clindata Cloud as their enterprise-wide data standardization and risk management platform. This provides the CRO with competitive advantage in the crowded CRO market and enables them to offer expanded value-added services to sponsors.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Castor: Cloud-native EDC platform widely adopted by academic and emerging sponsor studies, with overlap to Clindata on EDC data capture and CDISC-aligned outputs. A smaller, faster-moving competitor in the same buyer segments.
• BioFortis: Specializes in clinical research informatics, including CDISC-aligned data integration and analytics for translational and clinical research—closely aligned with Clindata's clinical data standardization theme, at smaller scale.
• Axiom Real-Time Metrics: Provides EDC, ePRO, and clinical data management services with a focus on small-to-mid sized sponsors, overlapping with Clindata in target buyer profile and core functionality.

Direct peers

• Veeva Systems: Veeva Vault CTMS / Vault EDC competes in the same clinical trial data management space and is widely used by large pharma. Comparable enterprise customer base, similar regulatory-grade integrations, and overlapping RBM/trial monitoring workflows.
• ArisGlobal: LifeSphere CTMS / EDC suite competes directly with Clindata Cloud in clinical trial data management, monitoring, and submission readiness for pharma and CROs.
• Medidata Solutions (Dassault Systèmes): Industry-leading Rave EDC/CTMS platform serving global Bio-Pharma sponsors with integrated clinical data capture, management, and analytics. Direct competitor to Clindata Cloud's EDC and risk monitoring functionality, with established enterprise contracts and a far larger footprint.
• Clinical Ink (Halo): Provides eCOA/ePRO and direct data capture with analytics for clinical trials, overlapping Clindata's clinical data capture, integration, and monitoring capabilities for sponsors and CROs.
• eClinical Solutions (elluminate): Offers clinical data analytics, EDC integration, and risk-based monitoring solutions for life sciences sponsors and CROs—directly comparable to Clindata's data standardization and RBM focus.

Broad incumbents

• IQVIA (Clinical Technologies): Large CRO with embedded clinical trial technology platforms serving Bio-Pharma sponsors; both a potential partner through the CRO channel strategy and a broad incumbent competitor across EDC and trial analytics.
• Oracle Health Sciences (Clinical One): Oracle's Clinical One platform offers EDC, RTSM, and trial data standardization for large sponsors as part of a broader health sciences portfolio. Overlaps with Clindata on CDISC-aligned data capture and is a broader incumbent that sponsors evaluate alongside niche tools.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/clindatainc

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Clinical Data