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EDC, eSource, and ePRO.

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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 chargefor costly products that may not be necessary in simpler studies.

· Integrate seamlessly with any additional eClinical tools that may be necessary using one ofMedrio’s 3 free APIs.

The ePRO functionality that device studies need· Accelerate the collection of patient reported outcomes with a cutting-edge applicationavailable via both web and mobile tablet.

· Enhance patient engagement through targeted follow-up, PRO surveys patients can completefrom 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 andCROs in the US and around the world:

500+devicestudies

80+device

organizations

Top-tiercustomersupport

Fast and Easy EDC

See these features in action! Check out our case study to see how a device sponsor implemented Medrio EDC and benefited from fast study build, easy training, and more.

Copyright ©2017 Medrio, Inc. www.medrio.com

1-800-498-6830 345 California St. Ste 325info@medrio.com San Francisco, CA 94104

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

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

Data Cleaning

Queries (Edit Checks/Data Discrepancies)• Cross Form and Visit Custom Query Definitions• Real-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

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

Fast and Easy EDC

Copyright ©2017 Medrio, Inc. www.medrio.com

1-800-498-6830 345 California St. Ste 325info@medrio.com San Francisco, CA 94104

Statistical Analysis

Built-In Functionality• Analysis by Visit• Box and Whisker• Descriptive Statistics and P-Values• Graphs• Histograms• Kaplan Meier Curve• Linear Regression• Multiple Linear Regression• Non-Linear Regression• Scatter Plots• Subgroup Analysis• Survival Analysis• Variables by Mean• Variables by Percent• Variables by Subject

Data Exports• Export to SAS, SAS Transport, SPSS, STATA, Excel, etc.• 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

Included Reports

Ad Hoc Reporting• Browse Data• Data Audit Log• Linked Data Report

Data Management • Missing Data (Variables Missing from Collected

Forms)• 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

Fast and Easy EDC

Copyright ©201 Medrio, Inc. www.medrio.com

1-800-498-6830 345 California St. Ste 325info@medrio.com San Francisco, CA 94104

Regulatory

Compliance

Privacy ShieldEQ5D

Features

Single Sign On (SSO)

Two-Factor Authentication (2FA)

Reason for Change to Data

Study Configuration

Study Build

• CDISC Compliance

Forms• Drag-and-Drop Interface

• Dynamic Forms• Data Dictionary

• Annotated CRFs

Study Management

Features

• Restrict Access to Site and Forms

• Japanese• French• German

Customer Success

Training

Support Portal

Customer Support

Fast and Easy EDC

1-800-498-6830 345 California St. Ste 325Copyright ©2017 Medrio, Inc. www.medrio.com info@medrio.com San Francisco, CA 94104

System Capabilities

Hardware

Windows

Web Browsers

• Safari• Chrome

eSource Applications

Technology

Fast and Easy EDC