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:

  • 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 [...]

  • Visual guide detailing Catchtrial EDC+ CDISC data journey, incorporating CDASH, SDTM, ADaM, and Define-XML alongside MedDRA coding and WHO Drug Dictionary dictionaries for safety data standardization.
    EDC▪18th June 2026▪7.1 min▪

    CDISC standards explained: SDTM, ADaM, CDASH

    What Are CDISC Standards? CDISC standards are a globally recognized set of data standards developed by the Clinical [...]

  • Promotional graphic highlighting Fastrial AI+ for clinical trial execution, illustrating integrated eClinical software features such as EDC, ePRO, Safety & MedDRA, imaging, and LMS with human expertise oversight.
    AI/ML▪18th June 2026▪3.2 min▪

    Fastrial AI+: ICH E6 R3-compliant AI for trials

    Fastrial AI+ is the AI operating layer embedded across Medigen Suite, built for compliance with ICH E6 R3 and [...]

  • Banner diagram explaining automated MedDRA coding for adverse events, highlighting time savings, consistency, and WHO Drug Dictionary integration for audit-ready safety data.
    EDC▪18th June 2026▪8 min▪

    MedDRA coding: how auto-coding saves hours per study

    What Is MedDRA Coding — and Why Does It Matter? MedDRA coding is the process of translating free-text adverse [...]

  • 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 [...]

  • Training Management System Why Trials Need Dedicated Validated LMS
    eLearning▪18th June 2026▪6.6 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 detailing eCOA vs ePRO capabilities, comparing ePRO questionnaires and symptom diaries with eCOA clinician, observer, and performance outcomes managed within the Medigen Suite platform.
    ePRO/eCOA▪18th June 2026▪7.2 min▪

    eCOA, ePRO, or both? How to choose the right patient data strategy for your trial

    Summary: eCOA and ePRO are two of the most valuable tools available for capturing meaningful patient data in clinical [...]

  • 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 [...]