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Medical Device Studies: Flexible Solutions That Keep You In Control

Solution Sheet

The process for bringing medical devices to market is increasingly complex. From regulatory challenges to the growing number of new data endpoints—device researchers, sponsors, and CROs need nimble tools that streamline their IP development lifecycle. At Medrio, we’ve worked with over 180 leading device companies across all phases of clinical study and we understand your need for agile solutions. Our integrated eClinical suite offers the flexibility and functionality to support your most complex randomization and bring your products to market faster.

Supporting Device Studies Since 2008

We’ve been supporting the Medical Device industry since 2008 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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Regulatory Approvals

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Customer Satisfaction

500+

Device Studies

180+

Device Organizations

115+

Regulatory Approvals

98%

Customer Satisfaction

Reduce Your Study Timelines

Build and deploy your device studies in a matter of days with flexible tools designed for fast data entry and data accuracy. With a few clicks of a mouse, device researchers can streamline query creation, deploy mid-study changes, and instantly upload bulk study data without technical support. 

And the best part? With access to reliable, high-quality data, your clinical teams can make proactive decisions that shorten your study timelines and streamline your product development. Our integrated eSuite of EDC, DDC, ePRO, eConsent, and RTSM keeps your trials running efficiently with user-friendly workflows and the robust functionality that your device studies need.

Delivering Better Data

  • Access and share real-time data from any device, anywhere 
  • Skip validation and focus on UAT with pre-validated software
  • Identify missing and duplicate data with live edit checks and logic-based workflows  
  • Export data in a snap with a host of on-demand queries, eCRFs, and custom reports
  • Respond quickly to AE notifications, missing data alerts, and out-of-range result triggers

Features to Sprint Your Device Studies 

  • Intuitive drag-and-drop interface puts you in control
  • Integrated eSuite with real-time, accurate oversight to your study teams 
  • Dynamic workflows enriched with complex skip logic, pre-set forms, and dictionary coding
  • Built-in functionality for statistical analysis and custom reports that don’t require IT support
  • Access to white-glove customer service and module-specific eLearning resources

Regulatory Compliance

  • Built-in Compliance—Good Clinical Practice (GCP), 21 CFR Part 11 Compliance, Annex 11, HIPAA, Privacy Shield, EQ5D 
  • Pre-Set Compliance Features—Pre-validated environment with built-in audit trails, Single Sign-On (SSO), SSL Encryption, Login and Activity Log, Two-Factor Authentication (2FA), edit checks, electronic signatures, session time-outs, and more.

We considered a number of EDC providers and chose Medrio because they have an excellent track record, a user-friendly system, and truly value the business of small to mid-sized organizations.

Randy Brown, Executive Vice President of Clinical Development, PAVmed

Solutions That Keep You in Control

Your device trials require oversight of many sites, samples, and IP shipments. Without proper oversight, your trials can experience delays that end up costing sponsors between $600,000 and $8 million each day. With access to live and remote data, user-friendly workflows, and logic-based validation, your teams can deploy mid-study changes without any need for programming support or downtime.

Conduct Cost-Efficient Studies

Costs keep steadily rising and now bringing a device to market can cost sponsors and CROs up to $500 million. Our transparent, subscription-based pricing model was designed to keep costs low in your medical device trials by eliminating programming expenses, adding unlimited sites at no extra cost, and only paying for features you need. Streamline your workflows with advanced reporting and risk-based monitoring that lower your cost of ownership and free up extra budget to reinvest elsewhere – such as site initiation or patient recruitment.

Connect Sites—Anytime, Anywhere

With secure offline and remote data sharing capabilities, device trial managers can deliver a feature-rich eSuite to their distributed network of study teams, sites, and sponsors. Consolidate your workflows by uploading bulk data and sharing remotely to your dispersed teams and ensure patient adherence by proactively tracking for AE/SAEs. Get access to our dynamic reports—on or offline—and stay up-to-date on remote site performance anywhere, anytime.

Having a good EDC with online/offline data capture that can record data on a tablet is crucial. And there are not many vendors that can provide that.

Jenny Li, Senior Manager of Clinical Operations, inui Health

A Better Way for Informed Consent

We know that patient understanding is an essential part of your trials’ success, and it begins with your consent process. eConsent offers a better way for your sites and study teams to reach patients, explain expectations, answer IP questions, and even enhance compliance—all without paper. Accelerate your consenting process without sacrificing global regulatory compliance and make comprehension easier for your subjects and sites. We promise you won’t miss the paper. 

ePRO That Device Studies Need

Nonadherence can make or break your studies, yet 40% of device study participants become non-adherent after the first 150 days. Our patient-centric ePRO was designed to increase your adherence and strengthen IP efficacy with robust functionality and a seamless EDC integration. Gain insight into your patient-reported and clinical data with fully compliant audit trails and pre-validated assessments. ePRO helps reduce patient burden while ensuring your data is more accurate and secure.

Single Solution for Randomization

Supply chain is a critical component of bringing a product to market. Your study timeline, budget, and overall success are closely tied to having the right IP available at the right place and time. Our flexible RTSM technology streamlines complicated supply chain considerations while minimizing IP waste and decreasing budget risk. We do this by offering a single, scalable solution for randomization and trial supply management that can adapt to any sample population size. We know your randomization challenges and how to solve them. Our RTSM solution and support team have delivered over 250,000 IPs to 2,400 sites in more than 50 countries.

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

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