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  • A promotional image for Medigen Suite featuring large text reading "21 CFR Part 11 password requirements: what the regulation actually says." A laptop displays a "User Management" interface on a clean office desk next to a notebook, pen, metal tumbler, and a blue padlock icon representing security.
    CTMS, EDC▪18th September 2026▪11.8 min▪

    21 CFR Part 11 password requirements: what the regulation actually says

    A 90-day password change is not a 21 CFR Part 11 requirement. Neither is a prescribed password length or [...]

  • Clinical trial software stack connecting EDC, CTMS, ePRO and AI across the study lifecycle
    CTMS, EDC, eLearning, ePRO/eCOA▪11th September 2026▪10.5 min▪

    Clinical trial software for the connected study stack

    Clinical trials are generating more data from more sources, while study teams are coordinating increasingly specialized workflows. Choosing clinical [...]

  • types of clinical trials
    EDC▪4th September 2026▪11 min▪

    A practical guide to the main types of clinical trials

    The type of clinical trial you run shapes almost every operational decision that follows, from protocol design and data [...]

  • SDV vs SDR in clinical trial monitoring, two professionals reviewing trial data on a laptop
    CTMS▪3rd September 2026▪9.2 min▪

    A practical guide to SDV vs SDR in clinical trial monitoring

    The real challenge with SDV vs SDR is not deciding which activity is better. It is knowing which monitoring [...]

  • electronic signatures with multi-factor authentication
    ePRO/eCOA▪1st September 2026▪12.7 min▪

    Confident eConsent in clinical trials across US, EU, UK and Switzerland

    Electronic informed consent is becoming an increasingly established option in clinical research, but regulatory acceptance does not mean that [...]

  • GDPR clinical trials
    EDC, ePRO/eCOA▪24th August 2026▪9.9 min▪

    GDPR in clinical trials: a 7-step guide for ClinOps

    GDPR compliance in clinical trials is rarely about one document or one department. It is about knowing what participant [...]

  • A professional reviewing a study start-up timeline chart on a whiteboard while holding a tablet. On the left side, the Medigen Suite logo appears next to the bold headline "Practical Ways to Reduce Clinical Trial Start-Up Delays." Sticky notes display "Parallel Workstreams," "Clear Visibility," and "Better Coordination."
    CTMS, EDC, eLearning▪20th August 2026▪11 min▪

    Practical ways to reduce clinical trial start-up delays

    Clinical trial start-up is complex by design. Regulatory approvals, contracts, site readiness, database build, training, supplies, and operational planning [...]

  • A professional woman working on a laptop at a desk, with data analytics dashboards displayed on a monitor behind her. On the left side, the Medigen Suite logo appears along with the bold text "The ROI of Unified eClinical Platforms.
    CTMS, EDC, ePRO/eCOA▪17th August 2026▪9.5 min▪

    The ROI of unified eClinical platforms

    When pharmaceutical R&D costs are measured in billions, technology efficiency becomes a strategic issue rather than an IT detail. [...]

  • single sign on and clinical trial software
    CTMS, EDC, ePRO/eCOA▪12th August 2026▪8.6 min▪

    Practical single sign-on for clinical trial software

    Smarter Single Sign-On for Global Clinical Trial Systems As clinical trials expand across countries, sites, systems, and external [...]