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:

  • Woman working on a laptop displaying clinical trial software dashboard, featuring Catchtrial and Maptrial logos, title text "Smarter Computer System Validation for Clinical Trial Software," and compliance icons for audit trails, electronic signatures, and validated systems.
    CTMS, EDC, ePRO/eCOA▪5th August 2026▪9.5 min▪

    Smarter Computer System Validation for Clinical Trial Software

    Every clinical database used for a regulatory submission depends on one assumption: the software performed as intended. Computer system [...]

  • Laptop on a desk displaying the maptrial Audit Trail interface with user logs, next to text reading "Building a Practical Audit Trail Strategy for eClinical Data," featuring Catchtrial and Maptrial logos.
    CTMS, EDC, ePRO/eCOA▪4th August 2026▪10.2 min▪

    Building a Practical Audit Trail Strategy for eClinical Data

    Most eClinical platforms used today are capable of capturing a comprehensive audit trail. The greater challenge is often not [...]

  • Graphic depicting a balance scale with digital dashboards on one side and medical monitors on the other, titled 'A Smarter Balance between Centralized and Onsite Monitoring'
    CTMS, EDC▪3rd August 2026▪8.7 min▪

    A Smarter Balance between Centralized and Onsite Monitoring

    Every monitoring plan has to answer the same practical question: how much oversight should happen at the site, and [...]

  • Infographic highlighting a decentralized clinical trial framework, featuring Medigen Suite eCOA and ePRO software interface screens for patient-reported outcomes, site performance, and global compliance.
    ePRO/eCOA▪24th July 2026▪7.4 min▪

    A Proven Hybrid Clinical Trial Model for Global Compliance

    A Proven Hybrid Clinical Trial Model for Seamless Global Compliance Sponsors conducting multi-regional clinical trials face dual imperatives: [...]

  • Hero image introducing ALCOA+ data integrity principles for cleaner clinical trial data with Medigen Suite showing a software dashboard and lab imagery.
    CTMS, EDC▪23rd July 2026▪8.5 min▪

    ALCOA++ Data Integrity Principles for Cleaner Clinical Trial Data

    Every regulatory submission rests on a simple assumption: the data behind it can be trusted. As trials grow more complex, [...]

  • Graphic by Medigen Suite titled "How a Dedicated ePRO App Can Strengthen Patient Data Quality", featuring a smartphone displaying an ePRO (electronic patient reported outcomes) symptom assessment questionnaire for an ePRO clinical trial alongside key benefits like data integrity and compliance.
    ePRO/eCOA▪17th July 2026▪7.6 min▪

    How a Dedicated ePRO App Can Strengthen Patient Data Quality

    ePRO Apps Deliver Cleaner Patient Reported Outcome Data Electronic patient reported outcomes, or ePRO, have become a core [...]

  • Graphic showcasing the Medigen Suite econsent platform, illustrating secure digital informed consent on a tablet and detailing how econsent software delivers compliant, traceable, and participant-first workflows for clinical research.
    eConsent▪16th July 2026▪6.4 min▪

    Choosing the Right eConsent Platform for Your Clinical Trial

    Clinical trials are moving fast toward decentralized and hybrid models, and paper consent forms simply can't keep up. Participants now [...]

  • Header graphic showcasing Mastertrial 21 CFR Part 11 LMS software, demonstrating inspection-ready training records, global site access, and advanced clinical trial data security for global clinical trials.
    eLearning▪10th July 2026▪7.3 min▪

    Choosing a Reliable 21 CFR Part 11 LMS for Trial Sites

    Clinical trial training is not just a logistical exercise. It is a regulated process that directly affects protocol compliance, [...]

  • Banner highlighting Mastertrial’s platform approach to clinical research associate training (CRA training), showcasing tools for engaging eLearning, knowledge validation, certified training completion, and real-time monitoring in clinical research training.
    eLearning▪28th June 2026▪5.8 min▪

    Smarter Clinical Research Associate Training for Global Trials

    Strong clinical research associate training is one of the most effective investments sponsors can make to improve trial quality, [...]