UNITYdx

UNITYdx
Product Description

Soterius offers its in-house tool, UNITYdx, which automates the sending and tracking of SUSAR notifications to the Principal Investigators (PI) during a clinical trial. System integration and standardization allow UNITYdx platform to work with any of the database systems. Continuous tracking provides audit reports and tracking for inspections. Multi-channel communication hub ensures prompt, compliant, efficient, and secure communication between Clinical Trial sites, Safety Teams (CROs and Sponsors), and Clinical teams.

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Soterius, Inc.

  • US
  • 2023
    On CPHI since
  • 50 - 99
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
View company profile
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Specifications
  • Details
    Soterius offers its in-house tool, UNITYdx, which automates the sending and tracking of SUSAR notifications to the Principal Investigators (PI) during a clinical trial. System integration and standardization allow UNITYdx platform to work with any of the database systems. Continuous tracking provides audit reports and tracking for inspections. Multi-channel communication hub ensures prompt, compliant, efficient, and secure communication between Clinical Trial sites, Safety Teams (CROs and Sponsors), and Clinical teams.
More specifications Fewer specifications

Soterius, Inc.

  • US
  • 2023
    On CPHI since
  • 50 - 99
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
View company profile

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Soterius, Inc. resources (1)

  • UNITYqa

    Brochure UNITYqa

    Our Software System is designed for performing Quality Assurance in case processing. This comprehensive system offers robust features to effectively manage and monitor error handling for both Periodic and Ad-hoc Quality Assurance processes.Key functionalities of our system include:• KPI Calculation: Effortlessly calculate Key Performance Indicators (KPIs) and error percentages or scores, providing valuable insights into the quality of case processing.• Compliance Reporting: Generate compliance reports across various variables such as case type, products, users, and more. These reports are invaluable for review and can be seamlessly incorporated into the Pharmaceutical Quality System Master File (PSMF).• Customizable Workflow: Tailor the workflow steps to suit the needs of different stakeholders, including Quality Control (QC) teams, Medical Review (MR) reviewers, vendor stakeholders, decision committees, and others.• Email Notifications