Medrio For Medical Device Studies

Simple, fast, and affordable tools for
the collection of data in clinical trials

Medrio offers eClinical solutions including EDC, eSource, and ePRO.

 

Sponsors and CROs entering medical device clinical trials require an EDC system as innovative and nimble as they are. Medrio is ideal for the straightforward study designs common in device research, and offers a fast and flexible ePRO tool that enhances your insight into the patient experience. 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 program in Medrio.

 

Fast and Easy

  • Build and deploy studies in as little as a few days, without relying on programming or IT staff.
  • Deploy mid-study changes with no downtime, change orders, or other delays.
  • Ensure fast data entry and data accuracy with robust logic-based validation.
  • Quickly and easily identify missing and duplicate data.

 

Ideal for straightforward study design

  • Pay only for tools and modules you need, instead of investing in eClinical packages that charge for costly products that may not be necessary in simpler studies.
  • Integrate seamlessly with any additional eClinical tools that may be necessary using one of Medrio’s 3 free APIs.

 

The ePRO functionality that device studies need

  • Accelerate the collection of patient reported outcomes with a cutting-edge application available via both web and mobile tablet.
  • Enhance patient engagement through targeted follow-up, PRO surveys patients can complete from home via email, and more.
  • Improve patient safety and adverse event detection with real-time monitoring.

 

Medrio has extensive experience in medical device clinical trials, and has worked with sponsors and CROs in the US and around the world:

 

 

Data Entry

Features

  • Repeating Forms and Visits
  • Dynamic Skipping and Hiding of Forms/Visits
  • Electronic Patient Reported Outcomes (ePRO)
  • 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 with Excel
  • 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

 

Data Cleaning

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)

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

 

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 Visit

  • Export 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

 

Reporting

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

 

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

Customer Support

  • Included Email Support 24/7
  • Included Phone Support 24/7

 

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

 

System Capabilities

Hardware

  • Desktop, Laptop, or Tablet
  • Operating System – iOS (iPad), Android, or Windows

Web Browsers

  • Microsoft Internet Explorer
  • Mozilla Firefox
  • Safari
  • Chrome

eSource Applications

  • Contact your Medrio representative for the list

eClinical Modules

Electronic Patient Reported Outcomes (ePRO)

  • Patients can Fill Out and Submit Surveys Online
  • Submitted Data Instantly Captured in Unified Database

Randomization

  • Generate Subject IDs or Sample Numbers
  • Assign Subjects Dynamically to Different Groups/Arms
  • Unblind Notifications

Dictionary Coding

  • MedDRA, WHODrug, VedDRA, and More

File Attachments

  • Attach Any File Typeup to 10mb per File

 

Integration

  • Integrate Medrio via our API
  • Data Imports/Exports via API
  • Sync with External Systems (IVRS, CTMS, etc.)
  • Event Based Calls to API

 

Paper/Hybrid Studies

Features

  • Generate and Track Data Clarification Forms (DCFs)
  • Double Data Entry
  • Printable CRFs as MS Word or PDF Files
  • Reports on Double Data Entry and DCFs

 

Included Reports

Ad Hoc Reporting

  • Browse Data
  • Data Audit Log
  • Linked Data Report

Data Management

  • Missing Data (Variables Missing from Collected Forms) Browse Data
  • Missing Forms (Forms not yet Collected)
  • Field Status Report
  • Scheduled Visits
  • Coding Report
  • Unblind Log Report
  • ePRO Form Collection Status

Monitoring/Approvals

  • Monitor Summary Report
  • Monitor Log Report
  • Approval Variable Report

Query Metrics

  • Top Queries Report
  • Query Aging Report
  • Query Rate by Site
  • Query Rate by Form
  • Query Rate by Field

Study Setup

  • Data Dictionary
  • Annotated Forms

Study Summary

  • Study Data Summary Report
  • Site Data Summary Report
  • Subject Data Summary Report
  • Weekly Enrollment
  • Subgroup Counts

 

Study Configuration

Study Build

  • Form and Variable Libraries
  • Unlimited Users, Sites, Forms, and Edit Checks
  • Enrollment Groups and Limits
  • Custom Branding
  • CDISC Compliance
  • CDASH Form Library Included

Forms

  • Drag-and-Drop Interface
  • Import Forms and Workflows from Previous Studies
  • Flexible Form Design
  • Dynamic Forms
  • Data Dictionary
  • eCRFs in Any Language
  • Annotated CRFs

 

Study Management

Features

  • Privilege-Based User Administration
  • Restrict Access to PHI Data
  • Restrict Access to Site and Forms
  • Single Sign-On for Multiple Studies
  • Document Sharing
  • Localization Support in:
    • Japanese
    • French
    • German

 

Technology

  • Built on MS SQL Server with .NET Technologies
  • Fully Hosted and Maintained by Medrio