{"id":3041,"date":"2025-01-15T17:04:53","date_gmt":"2025-01-15T16:04:53","guid":{"rendered":"https:\/\/ice-platform.com\/architettura\/"},"modified":"2026-03-13T11:23:56","modified_gmt":"2026-03-13T10:23:56","slug":"architettura","status":"publish","type":"page","link":"https:\/\/ice-platform.com\/en\/architettura\/","title":{"rendered":"Architecture"},"content":{"rendered":"\t\t
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The proprietary applications related to the platform ecosystem are:<\/p>\n

    \n
  • ICE\u00ae eCRF<\/strong>: Electronic Case Report Form<\/li>\n
  • ICE\u00ae ePRO<\/strong>: Electronic Patient Reported Outcome<\/li>\n
  • ICE\u00ae eTMF<\/strong>: Electronic Trial Master File<\/li>\n
  • ICE\u00ae CTMS<\/strong>: Clinical Trial Management System<\/li>\n<\/ul>\n

    All solutions feature a user-friendly<\/strong> web-based interface and are distributed as SaaS (Software as a Service)<\/strong> applications. Users only need a browser on their device to interact with the platform. Each application is developed with a multi-tenant architecture, enabling centralized and shared software management that optimizes resources, updates, and maintenance for every client. Development\u00a0and maintenance adopt the latest technologies to ensure security standards (e.g., OWASP Top 10).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Key Validation Activities<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    <\/p>\n

    Throughout the entire lifecycle of the system, we perform rigorous Computer System Validation (CSV\/CSA) activities to ensure our products meet the highest standards of quality and compliance with applicable regulations, including (FDA 21 CFR Part 11, Eudralex Vol. 4 Annex 11 and related guidelines, GDPR, HIPAA).<\/p>\n

    These activities include:<\/p>\n

    <\/p>\n

      \n
    • Validation Planning: <\/strong>We define a detailed plan outlining the objectives, resources, and timelines for system validation.<\/li>\n
    • Risk Analysis: <\/strong>We identify and assess potential risks associated with the system to ensure they are properly mitigated.<\/li>\n
    • Validation Testing:\u00a0 <\/strong>We conduct thorough testing to verify that the system is securely installed and functions correctly under all expected operating conditions.<\/li>\n
    • Detailed Documentation: <\/strong>We maintain complete and accurate documentation of all validation activities, including test results and any corrective actions. This ensures transparency and allows auditors to examine every aspect of the validation process.<\/li>\n
    • Review and Approval: <\/strong>Validation results are reviewed and approved by a team of experts to ensure compliance with regulatory requirements and corporate standards.<\/li>\n
    • System Updates: <\/strong>Every change or enhancement to the system or its configurations is tracked and authorized through a change management mechanism. Updates are executed and validated in a test environment before release.<\/li>\n<\/ul>\n

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      ICE Platform Development Timeline<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      \n\n \n
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      \n 2025<\/span>\n <\/div>\n <\/div>\n
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      DECEMBER <\/h6>

      <\/span><\/p>

      ICE\u00ae ePRO 1.1.0<\/strong> - System Updates and new features for a better management of patient questionnaire. <\/span><\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2025<\/span>\n <\/div>\n <\/div>\n
      \n
      OCTOBER <\/h6>

      <\/span><\/p>

      ICE\u00ae eTMF 3.11.0 - <\/b>Introduction of study visiblity and center specific for all users. <\/span><\/p> <\/div>\n <\/div>\n\n \n \n

      \n
      \n
      \n 2025<\/span>\n <\/div>\n <\/div>\n
      \n
      OCTOBER <\/h6>

      <\/span><\/p>

      ICE\u00ae eTMF 3.11.0 - <\/b>Introduction of study visiblity and center specific for all users. <\/span><\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2025<\/span>\n <\/div>\n <\/div>\n
      \n
      JULY <\/h6>

      <\/span><\/p>

      ICE\u00ae eCRF 3.11.0 - <\/b>ICE\u00ae readiness for developments in CDASH nomenclature and optimization of overall system performance. <\/span><\/p> <\/div>\n <\/div>\n\n \n \n

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      \n 2025<\/span>\n <\/div>\n <\/div>\n
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      JUNE <\/h6>

      <\/span><\/p>

      ICE\u00ae eCRF 3.10.0- <\/b>New section for drug management and optimization of existing functionality. <\/p> <\/div>\n <\/div>\n \n \n

      \n
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      \n 2025<\/span>\n <\/div>\n <\/div>\n
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      MAY <\/h6>

      <\/p>

      <\/p>

      Introducing electronic Patient Reported Outcome, ICE\u00ae ePRO 1.0.0<\/strong> \u2013 the innovative, validated web-based system that enables patients to directly complete electronic questionnaires, with the goal of improving both care and reporting. Thanks to ePRO, the collection of digital health data becomes decentralized, efficient, and reliable. <\/p> <\/div>\n <\/div>\n\n \n \n

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      \n 2025<\/span>\n <\/div>\n <\/div>\n
      \n
      MAY <\/h6>

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      ICE\u00ae eCRF 3.9.0 - <\/b>ePRO module, improvements to audit and eQuery functionality. <\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2025<\/span>\n <\/div>\n <\/div>\n
      \n
      JANUARY <\/h6>

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      ICE\u00ae eTMF 1.1.0 <\/strong>- The workflow for study closure and approval has been implemented, along with a new feature that enables document export based on user-defined filters. <\/p> <\/div>\n <\/div>\n\n \n \n

      \n
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      \n 2024<\/span>\n <\/div>\n <\/div>\n
      \n
      DECEMBER <\/h6>

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      ICE\u00ae eCRF 3.8.0 -<\/strong> Protocol deviation: new section to track open queries in this way.<\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2024<\/span>\n <\/div>\n <\/div>\n
      \n
      SEPTEMBER <\/h6>

      \u00a0<\/p>

      ICE\u00ae eCRF 3.7.0- <\/strong>IDE\/Editor: Added a new component called apibutton<\/em>, visible only through permission settings. Administration tools: Introduced a new button to enable visibility permissions for the apibutton<\/em> component. \u00a0<\/p> <\/div>\n <\/div>\n\n \n \n

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      \n 2024<\/span>\n <\/div>\n <\/div>\n
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      SEPTEMBER <\/h6>

      <\/p>

      Introducing electronic Trial Master File, ICE\u00ae eTMF 1.0.0<\/strong> \u2013 the digital system used to manage and archive the essential documents of a clinical study. It replaces the traditional paper-based Trial Master File (TMF), which contains the documentation required for conducting clinical trials.<\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2024<\/span>\n <\/div>\n <\/div>\n
      \n
      MAY <\/h6>

      <\/p>

      ICE\u00ae eCRF 3.6.0- <\/strong>PDF printing optimization; added drug coding functionality; added \u201cAssociate all sites\u201d option for users. <\/p> <\/div>\n <\/div>\n\n \n \n

      \n
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      \n 2024<\/span>\n <\/div>\n <\/div>\n
      \n
      FEBRUARY <\/h6>

      <\/p>

      ICE\u00ae eCRF 3.5.0<\/strong> - SAS Export: added new functionality for exporting data in SAS format. <\/p> <\/div>\n <\/div>\n \n \n

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      \n 2023<\/span>\n <\/div>\n <\/div>\n
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      NOVEMBER <\/h6>

      <\/p>

      ICE\u00ae eCRF 3.4.0 - <\/strong>Helpdesk: Ticket creation now available directly from ICE3. Event mail: Improved handling of \u201ccomponent value\u201d events. \u00a0<\/p> <\/div>\n <\/div>\n\n \n \n

      \n
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      \n 2023<\/span>\n <\/div>\n <\/div>\n
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      OCTOBER <\/h6>

      <\/p>

      ICE\u00ae eCRF 3.3.0-<\/strong> Integration with LimeSurvey for clinical data.<\/p> <\/div>\n <\/div>\n \n \n

      \n
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      \n 2023<\/span>\n <\/div>\n <\/div>\n
      \n
      SEPTEMBER <\/h6>

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      ICE\u00ae eCRF 3.2.0- <\/strong>URV Grid: Added a new section to better visualize all URVs completed by a patient. Clinical data import: Introduced a system for bulk importing clinical data.\u00a0<\/p> <\/div>\n <\/div>\n\n \n \n

      \n
      \n
      \n 2023<\/span>\n <\/div>\n <\/div>\n
      \n
      JULY <\/h6>

      <\/p>

      ICE\u00ae eCRF 3.1.0<\/strong> - Audit trail: Now subject only to soft-delete; eCRF file tracking: Added logging of downloaded uploaded eCRF files.<\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2023<\/span>\n <\/div>\n <\/div>\n
      \n
      MARCH <\/h6>

      <\/p>

      ICE\u00ae eCRF 3.0.0 Release - <\/strong>New Infrastructure of multitenancy. \u00a0<\/p> <\/div>\n <\/div>\n\n \n \n

      \n
      \n
      \n 2019<\/span>\n <\/div>\n <\/div>\n
      \n

      Nasce Clinical Trial Management System, ICE\u00ae CTMS 1.0 - <\/strong>che consente anche grazie al dialogo con le eCRF create dalla piattaforma ICE, di ottenere in tempo reale i dati necessari per monitorare il raggiungimento dei KPI delle sperimentazioni cliniche<\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n 2017<\/span>\n <\/div>\n <\/div>\n
      \n

      <\/p>

      ICE\u00ae eCRF 2.0.0<\/strong> - Go-live of the first clinical trials.<\/p> <\/div>\n <\/div>\n\n \n \n

      \n
      \n
      \n 2016<\/span>\n <\/div>\n <\/div>\n
      \n

      <\/p>

      Introducing Integrated Clinical Trial Environment, ICE\u00ae eCRF 1.0<\/strong> \u2013 the EDC platform for collecting and monitoring clinical data, an essential tool supporting clinical trials. <\/p> <\/div>\n <\/div>\n \n \n

      \n
      \n
      \n Sep
      2018<\/span>\n <\/div>\n <\/div>\n
      \n

      Lorem ipsum dolor sit amet, consectetur adipis icing elit, sed do eiusmod tempor incid ut labore et dolore magna aliqua Ut enim ad min.<\/p> <\/div>\n <\/div>\n\n \n \n <\/div>\n\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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      \n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

      The proprietary applications related to the platform ecosystem are: ICE\u00ae eCRF: Electronic Case Report Form ICE\u00ae ePRO: Electronic Patient Reported Outcome ICE\u00ae eTMF: Electronic Trial Master File ICE\u00ae CTMS: Clinical Trial Management System All solutions feature a user-friendly web-based interface and are distributed as SaaS (Software as a Service) applications. Users only need a browser […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"class_list":["post-3041","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/pages\/3041","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/comments?post=3041"}],"version-history":[{"count":231,"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/pages\/3041\/revisions"}],"predecessor-version":[{"id":4869,"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/pages\/3041\/revisions\/4869"}],"wp:attachment":[{"href":"https:\/\/ice-platform.com\/en\/wp-json\/wp\/v2\/media?parent=3041"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}