Daniele Zago

Daniele Zago is COO and Chief Digital Officer at Meditrial, where he leads the R&D/IT behind Medigen Suite. With 20+ years of experience spanning eClinical software and quality management, he has led the design of FDA-compliant EDC and CTMS platforms and managed audits by Notified Bodies, Competent Authorities, and medical device manufacturers under ISO 9001, ISO 13485, and ISO 27001. He previously lectured on EU MDR 2017/745 at Università Roma Tre and writes Medigen Suite's eClinical series.

Daniele Zago is COO and Chief Digital Officer at Meditrial, where he leads the R&D/IT behind Medigen Suite. With 20+ years of experience spanning eClinical software and quality management, he has led the design of FDA-compliant EDC and CTMS platforms and managed audits by Notified Bodies, Competent Authorities, and medical device manufacturers under ISO 9001, ISO 13485, and ISO 27001. He previously lectured on EU MDR 2017/745 at Università Roma Tre and writes Medigen Suite's eClinical series.

Explore this author’s articles:

  • Banner graphic demonstrating how Medigen Suite integrates CDISC standards into eCRFs from day one, converting clinical data standards into SDTM and ADaM submission-ready datasets for accelerated regulatory filings.
    CTMS, EDC▪24th June 2026▪6.5 min▪

    CDISC compliance built for faster trial submissions

    Many data managers encounter CDISC issues later than ideal in the study timeline. A field gets mapped inconsistently across [...]

  • Banner graphic for Catchtrial Safety software highlighting auditable endpoint adjudication, DSMB and CEC workflows, automated event allocation, and real-time concordance analytics for clinical research sponsors.
    EDC▪19th June 2026▪6.1 min▪

    Smarter Endpoint Adjudication for Clinical Event Committees and Sponsors

    When a serious cardiac event occurs at one site and a similar event occurs at another, sponsors need to [...]

  • Header graphic featuring Mastertrial LMS+ software on a laptop screen, highlighting study-specific eLearning, real-time dashboards, and certified training records designed to streamline protocol training and site readiness prior to site activation.
    eLearning▪18th June 2026▪5.8 min▪

    Confident Protocol Training for High Performing Study Sites

    Clinical trials rarely fall behind because of a single major issue. More often, delays begin with inconsistent training, incomplete [...]

  • Explanatory banner showcasing how eMVR streamlines CRA monitoring and remote site monitoring through automated SDV tracking, real-time query visibility, protocol deviation management, and CFR Part 11 compliant audit trails.
    CTMS▪18th June 2026▪8.4 min▪

    eMVR: Electronic Monitoring Visit Reports Explained

    Too Busy to Read the Full Article? Here's What You Need to Know An eMVR is an electronic [...]

  • Educational graphic detailing the transition from ICH E6 R2 to ICH E6 R3 GCP compliance standards in Catchtrial EDC+, showcasing risk-based oversight, data integrity safeguards, and global regulatory readiness for FDA, EMA, and PMDA.
    EDC▪18th June 2026▪7.2 min▪

    ICH E6(R3): How Your EDC Should Adapt to New GCP Rules

    The ICH E6(R3) guideline, finalized in January 2025, represents the most significant rewrite of Good Clinical Practice standards in [...]

  • Header graphic showing Mastertrial LMS+ on a laptop with study training progress bars, highlighting a 21 CFR Part 11 LMS and validated LMS built as a dedicated training management system for clinical trials.
    eLearning▪18th June 2026▪6.7 min▪

    Training Management System: Why Trials Need a Dedicated Validated LMS

    Summary: As clinical trials become increasingly complex, training management can no longer be treated as a purely administrative function. [...]

  • Infographic displaying an all-in-one CTMS clinical trial management system dashboard showing live data analytics for active studies, open issues, CRA monitoring visits, and site readiness metrics.
    CTMS▪18th June 2026▪3.9 min▪

    Clinical Trial Management System: Oversight to Insight

    How Maptrial CTMS+ software supports monitoring, training, and performance oversight in modern clinical studies As clinical trials increase [...]

  • Visual guide explaining why a unified eClinical platform and eClinical suite outperform siloed systems by connecting EDC, CTMS, eTMF, eMVR, site payments, ePRO, and eConsent in one eClinical software ecosystem.
    CTMS, EDC▪18th June 2026▪8.9 min▪

    eClinical Software: The Case for a Unified Platform

    Choosing the right eClinical software has become a genuine competitive advantage in clinical research. Sponsors and CROs now have [...]

  • Infographic displaying an EDC-integrated clinical trial imaging solution for imaging CRO teams and core lab reviewers, featuring real-time DICOM viewer capabilities, AI anonymization, and audit-ready data security.
    Medical Imaging▪18th June 2026▪2.9 min▪

    Clinical Trial Imaging: DICOM & Core Lab in Your EDC

    Integrated DICOM Imaging, Core Lab Workflow, and AI-Powered Compliance When imaging works seamlessly, everything moves faster In [...]