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Medical Device Studies: Flexible Solutions That Keep You In Control

Solution Sheet

Medrio is the market-leading EDC for medical device trials, offering eClinical solutions including EDC, DDC, eConsent, and ePRO/eCOA. Sponsors and CROs entering medical device clinical trials require an EDC system as innovative and nimble as they are. Medrio offers ideal functionality for study designs common in device research, including a unified ePRO tool that provides instant insight into patient-provided data. In the time it takes to develop and submit a spec sheet to your current EDC vendor, users can set up and deploy their next study in Medrio.

Supporting Device Studies Since 2005

We’ve been supporting the Medical Device industry since 2005 and we’ve learned a thing or two along the way. You can trust that our solutions can meet,  and even exceed your expectations.

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Device Studies

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Device Organizations

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Customer Satisfaction

500+

Device Studies

80+

Device Organizations

98%

Customer Satisfaction

Reduce Study Timelines

  • Build and deploy studies in as little as a few days – including ePRO/eCOA forms – without relying on programming or IT staff.
  • Pre-validated software allows you to skip validation and simply conduct UAT.
  • Deploy mid-study changes with no downtime, technical support, or other delays.
  • Ensure fast data entry and data accuracy with user-friendly workflows and robust logic-based validation.
  • Quickly and easily identify missing and duplicate data.

The ePRO Functionality Device Studies Need

  • Unification of EDC and ePRO/eCOA delivers feature-rich oversight to study teams.
  • Supports validated assessments such as the EQ5D, SF12, and others.
  • Collect patient-reported data on any device, at home or in the clinic.
  • Improve patient safety and adverse event detection with real-time monitoring.

Improved Data Quality and Patient Safety

  • Unified EDC, eConsent, DDC, and ePRO/eCOA enable real-time data access and remote monitoring.
  • Immediate notifications of AEs and out-of-range results allow for earlier intervention.

Check Out Our Features

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Data Entry

  • Repeating Forms and Visits
  • Dynamic Skipping and Hiding of Forms/Visits
  • Electronic Patient-Reported Outcomes (ePRO/eCOA)
  • Multiple Subject Data Entry
  • Automatic Subject Exclusion
  • Attach Images and Files to eCRF Pages
  • Double Data Entry
  • Dictionary Coding (MedDRA, WHODrug, and More)
  • Offline Data Entry
  • External Data Loading and Mapping
  • Complex Skip Logic / Dynamic Questions and Tables
  • Calculated Variables (Even Across Forms/Visits)
  • Carry-Over Data / Header Labels
  • Embed Text or Images Anywhere on Forms
  • Link Form Completion Guidelines
  • Field-Specific Mouse-Over Help
  • Tabular or Graphical Casebook Views
  • AE & SAE Log Forms
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Queries Edit Checks/Data Discrepancies

  • Cross Form and Visit Custom Query Definitions
  • AE & SAE Log FormsReal-Time Hard and Soft Edit Checks at the Point of Data Entry
  • Manual Query Creation, Resolution, Notes, and Listings
  • Missing Data Queries
  • Drag and Drop Query Creation (No-Programming)
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Data Review and Monitoring

  • Bulk Form Approval/Removal for PIs
  • Configurable Form Approval Workflow
  • Site/Subject/Visit/Form/Field Locking Ability
  • Targeted Source Data Verification
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Statistical Analysis

Built-In Functionality

  • Analysis by Visit
  • Box and Whisker
  • Descriptive Statistics and P-Values
  • Graphs
  • Histograms
  • Kaplan Meier Curve
  • Linear Regressions
  • Multiple Linear Regression

Data Exports

  • Analysis by VisitExport to ODM XML
  • Export Real-Time Data on Demand
  • Export Historical Snapshots
  • Export Queries
  • Export Submission-Ready Casebooks to PDF
  • Export eCRF Screenshots to PDF
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Reporting

  • Export Reports Directly to Excel
  • Save Custom Reports
  • Specialized Reports Available
  • Run Live, Ad Hoc Reports
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Customer Success

Training

  • On-Site Training Programs Available
  • Web-Based Teleconference Training
  • Train-the-Trainer Instruction

Support Portal

  • eLearning Tutorials and Accompanying Documents
  • Online Help Files and User Guide
  • How-To and Best Practices Guides
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Regulatory

Compliance

  • Good Clinical Practice (GCP)
  • 21 CFR Part 11 Compliance
  • Annex 11
  • HIPAA
  • Privacy Shield
  • EQ5D

Features

  • Validated Environment
  • Audit Trail
  • Access Level Restricted by Role
  • Single Sign-On (SSO)
  • Incremental and Daily Full Backups
  • SSL Encryption
  • Login and Activity Log
  • Two-Factor Authentication (2FA)
  • Edit Checks to Ensure Accuracy of Data
  • Electronic Signatures
  • Reason for Change to Data
  • Session Time-Out
  • Password Expiration
  • User Lock-Out

 

Ready to Experience the Medrio Difference For Your Medical Device Studies?