Gesund AI CRO

JSON twin: https://www.healthaidb.com/software/gesund-ai-cro.json

Company Name

Gesund.ai

Product URL

https://gesund.ai

Company URL

https://gesund.ai

Categories

• clinical Care
• administrative Operations
• patient Facing
• diagnostic Support
• Clinical
• Administrative
• Diagnostic

Summary

Gesund AI CRO is a platform that accelerates the validation of medical AI models, enhancing speed and reducing costs compared to traditional methods.

Description

Gesund AI CRO offers a comprehensive solution for conducting independent validation studies of medical AI models, utilizing a proprietary technology platform to streamline complex processes and minimize uncertainties, resulting in significant improvements in speed and cost over in-house or traditional CRO approaches.

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 9001:2015
• SOC 2 Type II
• FDA AI monitoring framework
• EU MDR
• AI Act

Company Founding

2019

Company Offices

• United States
• Germany
• United Kingdom
• France
• Italy
• Spain
• Australia
• Japan
• South Korea
• China

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• FDA regulations
• ISO 9001:2015
• SOC 2 Type II
• FDA AI monitoring framework
• EU MDR
• AI Act

Customers

• ScanDiags
• Trillium Health Partners

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Independent validation studies for medical AI models
• AI model R&D acceleration
• Flexible deployment options (cloud, on-prem, air-gapped)
• Comprehensive AI lifecycle management (training, validation, post-FDA approval monitoring)
• No-code collaboration interface
• Access to exclusive data and annotator services
• Automated audit trails and version control
• Regulatory compliance support (FDA, ISO 9001:2015, SOC 2 Type II)
• Bias detection and remediation tools
• Real-time AI performance monitoring
• Automated report generation for regulatory submissions
• Federated annotation and review workflows
• Human-in-the-loop validation processes
• Integration with existing data sources (PACS, cloud, on-premise)
• Support for multi-modal medical imaging (2D, 3D, microscopy)
• Inter-rater agreement measurement
• Model output comparison tools
• Bias and fairness dashboards
• Immutable documentation and audit trails

Id

SW1397

Integration Partners

• Merck
• Northpond
• 500 Global
• Merck AI
• National Institute of Standards and Technology
• The White House
• CancerX
• Digital Medicine Society
• Chai
• ScienceExchange AI
• Alid AI

Integrations

• PACS
• cloud storage
• on-premise data sources

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• AI Factory (in-house AI model R&D)
• AI CRO (managed service for validation studies)
• Annotation Module (medical AI annotation platform)
• Monitoring Module (FDA AI monitoring framework implementation)

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW1397

Product Name

Gesund AI CRO

Ratings

• 9.3 Quality of Support, G2
• 8.3 Opportunity Identification, G2
• 9.2 Playbooks, G2
• 5.6 Estimated ROI (payback period in months), G2

Regions Available

• United States
• Canada
• United Kingdom
• Germany
• France
• Italy
• Spain
• Australia
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• South Africa
• Nigeria
• Egypt
• Saudi Arabia
• United Arab Emirates
• Israel

Related Urls

• https://elion.health/products/gesund-ai

Release Year

2021

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Radiology
• Cardiology
• Oncology
• Neurology
• Orthopedics
• Dermatology
• Pediatrics
• Psychiatry
• Emergency Medicine
• Anesthesiology
• Obstetrics
• Gynecology
• Urology
• Gastroenterology
• Pulmonology
• Rheumatology
• Infectious Disease
• Endocrinology
• Hematology
• Nephrology

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Major OS/DB/hardware needs, or empty if SaaS-only

Target Users

• clinicians
• nurses
• patients
• admins
• payers

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• Our extensive market assessments revealed that Gesund AI CRO generates a 4X speed and 2X cost improvement compared to doing FDA validation studies in-house or with traditional CROs.
• Our AI Deployment and Evaluation Lab focuses on the critical problem of health AI developers validating their models on diverse, real-world data. With Gesund, we have a platform that makes such collaboration easy, and importantly, that lets us do this in an ethical, transparent, responsible and reproducible manner.

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Gesund.ai",
  "product_url": "https://gesund.ai",
  "company_url": "https://gesund.ai",
  "related_urls": [
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  "product_code": "SW1397",
  "summary": "Gesund AI CRO is a platform that accelerates the validation of medical AI models, enhancing speed and reducing costs compared to traditional methods.",
  "description": "Gesund AI CRO offers a comprehensive solution for conducting independent validation studies of medical AI models, utilizing a proprietary technology platform to streamline complex processes and minimize uncertainties, resulting in significant improvements in speed and cost over in-house or traditional CRO approaches.",
  "categories": [
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  "specialties": [
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    "Oncology",
    "Neurology",
    "Orthopedics",
    "Dermatology",
    "Pediatrics",
    "Psychiatry",
    "Emergency Medicine",
    "Anesthesiology",
    "Obstetrics",
    "Gynecology",
    "Urology",
    "Gastroenterology",
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    "Rheumatology",
    "Infectious Disease",
    "Endocrinology",
    "Hematology",
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  "regions_available": [
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    "Canada",
    "United Kingdom",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Australia",
    "Japan",
    "South Korea",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "South Africa",
    "Nigeria",
    "Egypt",
    "Saudi Arabia",
    "United Arab Emirates",
    "Israel"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "Australia",
    "Japan",
    "South Korea",
    "China"
  ],
  "company_founding": "2019",
  "deployment_model": [
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    "on_prem",
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  "os_platforms": [
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    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Independent validation studies for medical AI models",
    "AI model R&D acceleration",
    "Flexible deployment options (cloud, on-prem, air-gapped)",
    "Comprehensive AI lifecycle management (training, validation, post-FDA approval monitoring)",
    "No-code collaboration interface",
    "Access to exclusive data and annotator services",
    "Automated audit trails and version control",
    "Regulatory compliance support (FDA, ISO 9001:2015, SOC 2 Type II)",
    "Bias detection and remediation tools",
    "Real-time AI performance monitoring",
    "Automated report generation for regulatory submissions",
    "Federated annotation and review workflows",
    "Human-in-the-loop validation processes",
    "Integration with existing data sources (PACS, cloud, on-premise)",
    "Support for multi-modal medical imaging (2D, 3D, microscopy)",
    "Inter-rater agreement measurement",
    "Model output comparison tools",
    "Bias and fairness dashboards",
    "Immutable documentation and audit trails"
  ],
  "optional_modules": [
    "AI Factory (in-house AI model R&D)",
    "AI CRO (managed service for validation studies)",
    "Annotation Module (medical AI annotation platform)",
    "Monitoring Module (FDA AI monitoring framework implementation)"
  ],
  "integrations": [
    "PACS",
    "cloud storage",
    "on-premise data sources"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "FDA regulations",
    "ISO 9001:2015",
    "SOC 2 Type II",
    "FDA AI monitoring framework",
    "EU MDR",
    "AI Act"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 9001:2015",
    "SOC 2 Type II",
    "FDA AI monitoring framework",
    "EU MDR",
    "AI Act"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "ScanDiags",
    "Trillium Health Partners"
  ],
  "user_reviews": [
    "Our extensive market assessments revealed that Gesund AI CRO generates a 4X speed and 2X cost improvement compared to doing FDA validation studies in-house or with traditional CROs.",
    "Our AI Deployment and Evaluation Lab focuses on the critical problem of health AI developers validating their models on diverse, real-world data. With Gesund, we have a platform that makes such collaboration easy, and importantly, that lets us do this in an ethical, transparent, responsible and reproducible manner."
  ],
  "ratings": [
    "9.3 Quality of Support, G2",
    "8.3 Opportunity Identification, G2",
    "9.2 Playbooks, G2",
    "5.6 Estimated ROI (payback period in months), G2"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2021",
  "integration_partners": [
    "Merck",
    "Northpond",
    "500 Global",
    "Merck AI",
    "National Institute of Standards and Technology",
    "The White House",
    "CancerX",
    "Digital Medicine Society",
    "Chai",
    "ScienceExchange AI",
    "Alid AI"
  ],
  "id": "SW1397",
  "slug": "gesund-ai-cro",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/gesund-ai-cro.json"
  }
}