Electronic Trial Master File (eTMF) Software

Medrio CDMS/EDC is designed specifically for today’s clinical trials, with a cloud-based, intuitive interface that reduces build time and operational burden.

Unlike CDMS platforms that rely on custom coding, Medrio CDMS/EDC enables rapid study configuration, flexible mid-study changes, and streamlined workflows through point-and-click configuration. This helps teams move faster while maintaining compliance and data quality/security.

Medrio CDMS/EDC is designed to support regulatory compliance and data quality throughout the clinical trial lifecycle. The platform includes validated electronic records and signatures, full audit trails, role-based access controls, and secure data encryption to align with FDA 21 CFR Part 11, ICH E6(R2), HIPAA, GDPR, and other global requirements.

Medrio CDMS/EDC supports electronic data capture at the point of entry in ways that align with modern eSource expectations, helping reduce reliance on paper documents while maintaining full traceability. Robust data backup, disaster recovery, secure record access, and flexible data exports help ensure inspection readiness and long-term data accessibility.

Medrio CDMS/EDC supports clinical trials across MedTech, Biotechnology, Pharmaceutical, CRO/Consulting, and Animal Health organizations, from early feasibility studies through pivotal and post-marketing trials.

The CDMS/EDC platform is well suited for small and mid-sized teams as well as growing organizations that need enterprise-grade data management without enterprise-level complexity.

Compared to traditional enterprise CDMS platforms, Medrio CDMS/EDC emphasizes speed, usability, and flexibility. Teams often choose Medrio for faster study startup, easier eCRF design, and more responsive mid-study updates.

Compared to free, low-cost, academic, or open-source tools, Medrio CDMS/EDC provides stronger validation, scalability, and regulatory support required for regulated clinical trials.

Yes. Medrio CDMS/EDC is known for rapid study builds and efficient mid-study amendments. Study teams can implement form updates, logic changes, and protocol-driven modifications without lengthy revalidation cycles, reducing downtime and keeping studies on track. Customers have full control over these processes, without relying on Medrio as a vendor.

With Medrio CDMS/EDC, fast study start-up timelines are supported by no-code, point-and-click eCRF builds that don’t require specialized resources to configure and launch.

Medrio CDMS/EDC supports continuous data review and validation throughout the study, helping teams reduce late-stage cleanup at milestones such as Last Patient Last Visit (LPLV). Built-in edit checks, real-time validation, and efficient query workflows allow issues to be identified and resolved earlier.

Flexible mid-study updates and rolling database locks help teams avoid unnecessary rework, enabling faster progression from LPLV to database lock and shorter timelines for analysis and reporting.

Medrio CDMS/EDC is flexible enough to support adaptive protocols, complex visit schedules, hybrid models, and decentralized trial components. Its configurable workflows and integration capabilities allow sponsors to tailor data collection to evolving study designs and operational needs.

Yes. Medrio CDMS/EDC integrates with eConsent, RTSM/IRT, eCOA/ePRO, safety systems, and other eClinical technologies. The platform also supports industry standards for data capture and export, enabling interoperability and reducing manual data reconciliation.

Yes. Medrio provides onboarding, enablement, and ongoing support for customers using Medrio CDMS/EDC. Customers receive study setup guidance, best practices for data management workflows, and responsive assistance throughout the study lifecycle to help teams use the platform effectively.

Learn more at the Medrio Community forum.