AI & Efficiency

Leveraging software engineering, data science, imaging science, clinical operations and regulatory knowledge our AI-Smart technology platform that revolutionizes drug discovery and medical device trials by resolving inefficiencies through AI automation on the cloud.

You can focus on your cored operational activities while our platform’s automation workflows streamlines site accreditation, image tracking and site monitoring activities. Radiologists can focus on the disease assessment while our simple AI-guided streamlined workflows perform real-time compliance checks for screening, staging, and therapy evaluation to ensure reads are accomplished on time with the highest read quality standards.

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AI-Smart Trial Management

  • Site accreditation
  • Image tracking
  • Site management

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AI-Smart Image Cataloging

  • PHI removal
  • Image labeling & QC
  • Image selection for analysis

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AI-Smart Image Assessments

  • Guided Read data compliance checks
  • Reproducible image analysis

Imaging Assesments

Wide variety of imaging assessments from standard to advanced criteria are available in the platform to support your radiological assessment or clinical trial needs.

Standardized reporting for staging, eligibility, and response evaluation for oncology assessments, lung and advanced novel biomarkers.

Further customization possible to meet your qualitative and quantitative disease assessment needs.

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Oncology

  • RECIST 1.1
  • irRECIST
  • iRECIST
  • Choi
  • Lugano
  • RANO
  • mRANO

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Lung

  • COPD
  • ILD
  • Airway
  • Volumetrics

Dashboard Metrics

Monitor trial health from the study, site to the subject-levels through our hierarchical dashboards.

Web and mobile access to imaging trial dashboards, reminders on activities, and real-time study reports anywhere and anytime.

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Dashboards

  • Site Accreditation Status
  • Subject Scan Status

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Reminders

  • Site Management
  • Scan Tracking

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Reporting

  • Study Reports – Site Accreditation, Subject Scans
  • Image QC and Eligibility
  • Data Exports (SDTM)

Integration

Platform offers out-of-the-box support for all major electronic image exchange platforms and electronic data capture (EDC) systems.

Retrieve DICOM images from imaging exchange platforms and push analysis reports to reporting systems or configure to pull or push reports and clinical data to and from electronic data capture systems.

On your request, we can also work with academic labs and industry startups to integrate custom algorithms and/or software into our platform with regulatory compliance.

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Electronic Image Transfer

  • Auto fetch DICOM images
  • Route reports

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Electronic Data Capture

  • Latest clinical data retrieval
  • Automated upload image QC and eligibility reports

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Custom Integrations

  • REST API
  • SFTP
  • Custom PaaS & SaaS integration

Security & Regulatory

Data and services are securely hosted on AWS cloud following the industry best-practice data protection and privacy standards in compliance with HIPAA and GDPR requirements.

Software is 510(k)-cleared and 21 CFR Part 11 compliant.

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Cloud Security

  • Secure user access using centralized identity management
  • Real-time threat monitoring and prevention
  • Encryption at-rest and in-transit
  • Secure API access
  • Cybersecurity insurance

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FDA 510(k)

IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:

  • Oncology, including lesion marking and analysis
  • Anatomic structure marking, volume measurement and analysis
  • Only DICOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis. Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.

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FDA Part 11

IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) complies with FDA 21 CFR Part 11.

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HIPAA & GDPR

  • Complies with United States Health Information Portability Accountability Act (US HIPAA)
  • Complies with European Union’s General Data Protection Regulation (EU GDPR)