EDC

Medrio CDMS/EDC is a modern, unified Electronic Data Capture and Clinical Data Management platform purpose-built for clinical trials. It combines an intuitive user interface, seamless online and offline data capture, and comprehensive data management in a single cloud-based solution. The platform is designed specifically for small to mid-sized sponsors, CROs, and growing life sciences organizations across MedTech, Biotechnology, Pharmaceuticals, Animal Health, and consulting sectors — from early feasibility studies through pivotal and post-marketing trials.

Unlike legacy CDMS platforms that rely on custom coding and lengthy implementation cycles, Medrio CDMS/EDC enables rapid study configuration through no-code, point-and-click tools. Teams can go live in hours to days, implement mid-study changes without downtime, and move confidently toward database lock and regulatory submission.

Core Platform Capabilities

• No-code, point-and-click eCRF design that does not require specialized technical resources to configure and launch
• Reusable study template library and study copy functionality for faster study setup
• Real-time data visibility with dynamic reports and easy data exports
• Online and offline data capture capabilities supporting decentralized and hybrid trial models
• Continuous data review and validation throughout the study lifecycle
• Built-in edit checks and real-time validation to identify and resolve issues earlier
• Efficient query management workflows with straightforward audit trails
• Rolling database locks and flexible mid-study updates to reduce rework and shorten timelines from Last Patient Last Visit (LPLV) to database lock

Study Build and Mid-Study Efficiency

• Studies can be built up to 9 weeks faster compared to traditional approaches
• Mid-study changes can be completed in as little as one day with zero downtime
• Teams can test changes thoroughly before implementation to ensure seamless integration
• Customers retain full control over form updates, logic changes, and protocol-driven modifications without relying on the vendor
• Automated workflows and intuitive tools minimize rework and cut costs
• Sponsors and CROs have achieved database lock times reduced by up to 24 days using Medrio

Compliance, Security, and Inspection Readiness

• Validated electronic records and signatures aligned with FDA 21 CFR Part 11, ICH E6(R2), HIPAA, GDPR, and other global regulatory requirements
• Full audit trails and role-based access controls
• Secure data encryption, robust data backup, and disaster recovery capabilities
• Supports electronic data capture at the point of entry consistent with modern eSource expectations, reducing reliance on paper documents while maintaining full traceability
• Flexible data exports to support inspection readiness and long-term data accessibility

Trial Design Flexibility

• Supports adaptive protocols, complex visit schedules, hybrid models, and decentralized clinical trial (DCT) components
• Configurable workflows allow sponsors to tailor data collection to evolving study designs and operational needs
• Suitable for early feasibility studies through pivotal and post-marketing trials

Integrations and Interoperability

• Integrates with eConsent, RTSM/IRT, eCOA/ePRO, safety systems, and other eClinical technologies
• Supports industry standards for data capture and export to enable interoperability and reduce manual data reconciliation
• Compatible with remote data capture technologies that support decentralized clinical trials

Onboarding, Training, and Support

• Dedicated onboarding and enablement resources for new customers
• Study setup guidance and best practices for data management workflows
• Consistent team assignment from study start through completion
• Ongoing responsive support throughout the study lifecycle
• Access to the Medrio Community forum for additional resources

Medrio CDMS/EDC is a cloud-based platform with a 98% customer retention rate, serving life science innovators across medical technology, biotechnology, pharmaceuticals, CROs, and animal health. It is positioned as a faster, more flexible alternative to enterprise platforms such as Medidata Rave and Veeva Vault, while providing the validation, scalability, and regulatory support required for regulated clinical trials — capabilities that go beyond free or open-source tools such as REDCap or OpenClinica.