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Study Configuration

Study managers use a web-browser to configure Medrio for their unique study design. Medrio saves study managers time by automating whenever possible and providing customizable templates. This gives unprecedented speed and agility: have your study online in a matter of days, and modify the study at any time, without hiring programmers or starting from scratch for each study.

No Programming

By eliminating the need for custom programming, Medrio allows for faster study deployments, lowered costs, and more control over your study and study changes.

Configurable Form Layout

Enhance your form layout with Medrio's form configuration options. Change background colors, create borders, add images to forms, arrange form elements in tables, create repeating log forms, and more.

Form Libraries

To speed up study configuration further, Medrio contains form libraries from which forms can be directly imported to studies.

Create Custom Variables

Create custom variables in addition to loading pre-defined variables from Medrio's variable library. Customize variable details including data type, export details, units, PHI, label position, and more.

Configure Edit Checks & Queries

Medrio contains powerful yet simple tools to configure your study design within the website. No programming is required to build validation ranges for both "soft" and "hard" edit checks, required fields, multivariate, cross form and visit, and other essential checks you would expect from a powerful eClinical software.

Setup in Weeks Not Months

Stay in control of your timeline with Medrio's self-configured study set up. Medrio allows your study to go live when you are ready, whether it's a matter of days, weeks, or months. Deploy with the click of a button. Contact a Medrio expert for a demonstration of our quick build and deployment today!

Make Mid-Study Changes Easily at Any Time

Study configuration can be accessed in a safe environment to make, test, and deploy study changes at any time.

Data Entry

Improve your data quality with built in edit checks and double data entry. Data can be entered anywhere the web is accessible, or it can be entered offline in Excel and subsequently uploaded into Medrio.

Offline Data Entry

No additional study configuration is required to enable offline data entry access to users within your study. Excel versions of eCRF pages may be exported with a click within the website and then uploaded after data entry. There are many uses of this tool including enabling sites with intermittent internet access or the manual importing of other data such as PK or lab results. The Excel file contains many of the same range checks and form rules that were configured within the website and a complete validation is performed by the website before data is uploaded.

Support for Paper Processes

Using Medrio, you are able to manage an EDC, paper or hybrid study all within the same website. The key functionality included to support a paper study is the availability of double data entry and the generation and tracking of data clarification forms with reporting surrounding these activities.

Access from Anywhere

Access your study all over the world, anywhere with an internet connection. Medrio has collected data on all continents, and is available offline via excel at any time.

Dynamic Forms and Skip Logic

Medrio supports skip logic in which an entry may disable or remove subsequent entries within a form as well as designation of form rules or "dynamic forms" which can enable form skipping or the provision of different forms or sets of forms to be provided to different groups, cohorts, languages and more.

Edit Checks

Validation ranges for both "soft" and "hard" edit checks, required fields, multivariate, cross form/visit, and other essential checks and queries all respond immediately at the time of data entry, allowing for both end users and study managers to have real time access to discrepant data.

Electronic Patient Reported Outcomes (ePRO)

You can configure 100% of the forms, reports, data extraction, etc. through a web browser. This means you can be ready to collect ePRO data directly from patients online the day you contact Medrio.

Randomization

Medrio has a fully integrated randomization feature. Generate random subject IDs, sample numbers, or assign subjects to different groups, treatments or arms of a study.

Easy to Use

Medrio's intuitive data entry makes it easy to use for physicians who may not be experienced in clinical trials. Medrio's instinctive, user-friendly, and highly dynamic workflows reduce site burden and promote clean data. Minimal training is required with Medrio. Medrio is also designed to allow for seamless navigation for all users' roles within the website. Medrio does not require navigation into separate portals based on role, but rather removes tabs, links and other access for users who are not granted specific permissions.

Study Management

Medrio puts the power in the hands of data managers, who can manage every facet of all Medrio studies from our website. In Medrio you will observe data capture through real time field monitoring, control data integrity with range checks and custom queries that fire as data is entered, and oversee live data through our dozens of standard reports and ad-hoc reporting tools. All data is accessed in real-time by users whose roles you configure.

Field and Form Level Monitoring

Medrio has made the process of form monitoring and sign off completely configurable. You are able to create as many steps as necessary to match your workflow and then designate permissions for users to perform these steps. There is much granularity you can add to this process including which forms need sign off, whether partial monitoring is enabled for field level monitoring, whether queries may exist, whether queries automatically unlock and more. You can perform these sign offs at the field, form, subject, visit, site or study level.

Query Management

Medrio contains many tools to manage your discrepant data. Queries can be configured to fire for missing data, out of range values, as well as more complex query definitions including multiple variables and across multiple forms and/or visits. Manual queries can also be submitted at the field level. Queries can be managed at the form level through a comprehensive and filterable query listing and other reports designed to assist monitors and other users of the system. Reports include a monitor log report, monitor summary report, query aging, and query rates by field, form and site.

Create email alerts for SAEs, protocol deviations or other events

You are able to schedule notifications of events to users or non-users of Medrio via email. This is commonly used to send alerts for serious adverse events, protocol deviations or other events.

Role-Based User Administration

Customers are able to manage the administration of users through a link in the website. Medrio has a role-based user administration which allows flexibility for you to create and maintain your own roles within the system. Examples of roles available are data entry, reporting, raw data, configure study, etc. and you can restrict access to sites and forms.

Visit Schedules

Increase visibility to your study progress by using Medrio's dynamic visit schedules for subjects in your study.

Keep Full Control of Data

Maintain complete control of your data while working inside Medrio; analyze your data within the system or perform exports at any time.

Dictionary Coding

Medrio's rich feature set includes a coding module, supporting popular coding dictionaries like MedDRA and WHO Drug in addition to custom coding dictionaries. Use our intuitive auto-coding system to code data fast and accurately within our system.

Study Analysis

Medrio contains analysis tools within the website that do not require programming and are available as soon as you have study data. You have the ability to do further analysis outside of Medrio with our on-demand data exports to SAS, Stata, SPSS etc. In addition, Medrio automatically creates posters and PowerPoint presentations which include design and insertion of the analysis available. A list of the analysis features are below, some of which have tables and graphs included.

Analysis of Data

• Descriptive Statistics
• P Values
• Multivariate analyses
• Subgroup Analyses
• Regression (linear, multiple linear, non-linear, logistic)
• Kaplan Meier (e.g. Survival Curves]
• Analysis by Visit
• Box and Whisker
• Histogram
• Variables by Mean, Percentage and Subject
• Scatter Plot

Patient Profiles

Full patient profiles are available in PDF format on a site-level or study-level basis. Easily track data and historical changes for any patient in your study.

On Demand Data Exports

Access your data at any time with our real time data export feature. Medrio can support the format of your choice: export to SAS, SPSS, STATA, Excel, and more.

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