{"id":5114,"date":"2026-03-04T10:02:10","date_gmt":"2026-03-04T09:02:10","guid":{"rendered":"https:\/\/trigas-trigas-kunden.digitalspital.de\/study-management-and-monitoring\/"},"modified":"2026-04-17T16:09:55","modified_gmt":"2026-04-17T14:09:55","slug":"study-management-and-monitoring","status":"publish","type":"page","link":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/study-management-and-monitoring\/","title":{"rendered":"Study Management and Monitoring"},"content":{"rendered":"\t\t
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Certainty from Planning to the Final Report<\/h4>\t\t\t\t<\/div>\n\t\t\t\t
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IVD Study Management & Monitoring with TRIGA-S<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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TRIGA-S supports your study management from planning through the final report. We deliver audit- and submission-ready study documentation in compliance with ISO 20916, IVDR, and CFR.<\/p>

All our services can be booked individually or as a complete package \u2013 precisely according to your needs.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tExplore our services<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tDiscuss your study now<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\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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Your Benefits with TRIGA-S<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tRegulatory Security from Day One\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tYour study meets all current requirements: ISO 20916:2024, IVDR, and CFR. We know the pitfalls and proactively eliminate them. \t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\t\n\t\t\t\t\t\t\tAudit-Proof Data Quality\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tComplete, traceable documentation (TMF\/eTMF), risk-based monitoring, and real-time dashboards give you continuous oversight and data integrity that stands up to any audit.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\t\n\t\t\t\t\t\t\tFaster Market Access\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tStructured data collection forms, careful site selection before study start, and thorough preparations by our well-coordinated team shorten setup times and minimize rework.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\t\n\t\t\t\t\t\t\tNo Expensive Delays\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tWe identify risks early, preventing unnecessary project delays. This keeps your processes predictable and avoids expensive surprises. \t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\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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Our services in detail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t
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Study Management & Monitoring<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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All services at a glance \u2013 jump straight to the topic you need.<\/p>\t\t\t\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\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tStudy Design & Planning<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tStudy Preparation<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tSite Selection & Management<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tStudy Monitoring<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tRegulatory Support<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tStudy Completion & Reporting<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tData Quality & Data Protection Standards <\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\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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Study Design & Planning<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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First steps count. A well-conceived, scientifically sound study design based on current literature and regulatory requirements is the foundation for your success.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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We integrate data collection, monitoring, and analysis into one streamlined workflow for these<\/strong> study types:<\/strong><\/p>