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StudyGen 360 Logo

Solution for managing clinical study data and reporting

Table of Contents

StudyGen 360 - 2026 Pricing, Features, Reviews & Alternatives

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StudyGen 360 overview

What is StudyGen 360?

StudyGen 360 is a modern data platform that revolutionizes the collection, management, and analysis of clinical trial data at the laboratory level. The application offers flexibility by providing researchers with tools for seamless data processing and advanced analytics while streamlining regulatory reporting through automation.

StudyGen 360 works with a centralized, cloud-based data repository. This innovative approach removes the limitations associated with conventional systems, giving researchers the freedom to navigate and utilize study-related information without restrictions. StudyGen's versatility is evident in specialized modules designed to meet the unique needs and scientific challenges in different fields. The bioanalytics module allows researchers to delve into complex biological data, while the immunogenicity module enables in-depth investigation of immune responses. A stability module ensures accurate assessment of product stability over time, and the archiving module simplifies secure storage and retrieval of important study information based on authorities' requirements.

With StudyGen 360, you can be confident that your study data is in safe hands and benefit from a dynamic and adaptable platform tailored to the specific needs of your individual demands.

Key benefits of using StudyGen 360

  • Streamlined operations: Efficient and secure automated solutions ensuring data integrity, independent of instrument types or LIMS software.
  • Enhanced efficiency and transparency: Tailored workflows for seamless CRO-Sponsor collaboration, incorporating DTA and sample reconciliation.
  • Adaptable data management: Versatile data import capabilities from diverse sources (Analyst, SoftMax Pro, Excel, PDF, CSV, Oracle DB, SQL Server), providing flexibility in handling information.
  • Regulatory compliance: Stringent adherence to 21 CFR Part 11 requirements, with preconfigured reports aligned to ICH M10 and 2018 FDA Guidance (MVA).
  • Preconfigured table and graphs: Access to preconfigured tables and graphs, customized for various bioanalytical analysis types and experiments, including toxicology, clinical analyses, and validation experiments.
  • Tailored template editing: Integrated layout editor offering advanced functions for creating templates that meet specific sponsor requirements.
  • Starting price


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    StudyGen 360 reviews

    Overall rating

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    Rating breakdown
    • Value for money
    • Ease of use
    • Features
    • Customer support
    Rating distribution

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    StudyGen 360's features

    21 cfr part 11 compliance
    Access controls/permissions
    Ad hoc reporting
    API
    Audit management
    Audit trail
    Clinical study management
    Customizable reports
    Data capture and transfer
    Data import/export
    Data synchronization
    Data verification
    Data visualization
    Digital signature
    Document management
    Document storage
    Electronic data capture
    Inventory management
    Progress tracking
    Real-Time data
    Real-Time reporting
    Reporting & statistics
    Role-Based permissions
    Third-Party integrations
    User management

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    StudyGen 360 integrations (3)

    StudyGen 360 support options

    Typical customers

    Freelancers
    Small businesses
    Mid size businesses
    Large enterprises

    Platforms supported

    Web
    Android
    iPhone/iPad

    Support options

    Email/Help Desk
    FAQs/Forum
    Knowledge Base
    Chat

    Training options

    Live Online
    In Person
    Webinars
    Documentation

    StudyGen 360 FAQs

    Q. Who are the typical users of StudyGen 360?

    StudyGen 360 has the following typical customers:
    Large Enterprises, Mid Size Business, Small Business

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    Q. What languages does StudyGen 360 support?

    StudyGen 360 supports the following languages:
    English, German


    Q. Does StudyGen 360 offer an API?

    Yes, StudyGen 360 has an API available for use.


    Q. What other apps does StudyGen 360 integrate with?

    StudyGen 360 integrates with the following applications:
    SampleManager LIMS, LabVantage, LabWare LIMS


    Q. What level of support does StudyGen 360 offer?

    StudyGen 360 offers the following support options:
    Email/Help Desk, FAQs/Forum, Knowledge Base, Chat

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