Evado Clinical Products

Evado Platform is an integrated environment for the design, collection and management of clinical research data.

Evado eConsent enables sites to record a patient’s consent to participate in a trial, study or registry

Evado Data Collection is an end to end EDC platform for clinical research.

Evado Registry, supports chronic disease and patient recorded outcome registries. Evado’s fully enabled mobile solution includes ePro and eConsent.

Evado’s Patient Recorded Observation (ePRO) module enables patients to directly enter observations

Evado’s CTMS can be run standalone or integrated into the data collection module.

Evado Onsite Helper provides an outsourced monitoring and data management service for sponsors who are managing their own trials, studies and post market activities.

Evado’s award winning research platform is a device agnostic fully integrated mobile device environment that is powered by UniFORM’s patented technology.

 

Evado Platform

The Evado platform is an integrated environment for the design, collection and management of clinical research data. Evado is highly intuitive and very easy to use, yet powerful enough to manage large clinical research projects across multiple clinical sites.

Users do not need to program or modify software to implement Evado’s form driven engine. Evado’s intuitive interface streamlines the collection, validation and management processes necessary for clinical trials, studies and registries.

Features include:

  • High application availability, Evado does not need to be offline for maintenance.
  • Fast response times to page submits
  • An unlimited number of trials, studies and registries can be run simultaneously in the one environment.
  • Users can independently set up and run trials, studies and registries
  • Manages 1 – 500 concurrent users
  • Supports multiple sites.
  • Stores data from 1 – 10,000 clinical trials, studies or registries
  • Support for multiple data collection schedules, each schedule is versioned independently
  • New schedule versions do not affect historical data collection.
  • Data collection schedules can be design offline using a standard spreadsheet.
  • Evado architecture ensures that schedule or form versioning does not affect pre-existing project data.
  • Electronic source data collection.
  • Evado is fully mobile enabled and can be accessed from a mobile device of choice including iOS, Android, MacOS or Windows 10.
  • Evado integrate services enables external data to be imported into trials, studies or registries.
  • Fully encrypted audit trail of all user transactions.
  • Users can collect images and files in the file management system that can be included in a clinical project.
Integration services

Evado integration services include:

  • SAS ODBC query of exported statistical data
  • Web service interface to Evado content
  • Query and download Evado form records.
  • Generation of Evado CRF records using web services
  • Creation of new CRF pages
  • Creation of new AEs, SAEs or concomitant medication.
  • Web service based statistical data export
  • Batch upload of CRF records.
  • Export and download of statistical data
Project reporting

Evado provide a powerful reporting module:

  • Project managers can design reporting templates for both standard and ad-hoc reports.
  • Report templates can be used to generate: operation, monitoring or data management reports.
  • Users can select and execute reports on single or multiple projects.
  • Report data can be viewed in a web browser or a mobile device, or exported as: Html pages, or CSV files for further analysis.
File management services

Users can collect images and files in the file management system that can be included in a clinical project.

Features include:

  • Users can upload files as part of the trial or registry data collection process.
  • The file collection is fully integrated into the trial or registry data collection processes.
  • The metadata is stored in the Evado database
  • Files can be accessed by all registered users.
  • Multiple files can be uploaded as part of any patient visit.
  • Multiple trial or registry specific documents can be uploaded.
  • Multiple site specific documents can be uploaded
  • Provides a common repository for storing files across all Evado customer projects.
  • The file repository has been designed to store very large numbers of files.
  • External files or images can be uploaded at:

    • Clinical trial or registry level.
    • Clinical site level
    • At part of a patient’s demographic data
    • During a subject visit
    • As an ancillary record.
  • Multiple versions of a document or files can be uploaded and stored as different versions of the same file.
Evado mobile services

Evado UniFORM provides user with direct access to Evado’s eClinical platform.

Key Features

  • Evado Mobile is a lightweight data collection that can be run on IOS or android phones and tablets, or MacOS or Windows 10.
  • Full access to all Evado trial, study and registry features.
  • Integration with the device’s smart features.
  • Sites and Monitors can perform all their data collection activities using a mobile device.
  • Take a photo with your camera
  • Scan a barcode
  • Make phone calls or email directly from a smart device.
  • Users are authenticated each time they access the app.
  • Evado Mobile has been designed to provide a secure mobile environment for data collection.
  • Evado logs every user transaction with time and date stamps.
Privacy management
  • Evado conforms to International Quality and Health Standards and personal and patient privacy regulations.
  • Evado’s strict privacy protocols ensure that non-study sites can access patient personal data.
  • All patient personal and private data is encrypted prior to storage in the database using an automated key management process.
  • Only the patient and users at the clinic the patient is attending can view and update the patient’s person information.
  • All other users have de-identified access to patient records.
Security:

  • Evado is integrated into Active Directory to provide a multi-layered security architecture.
  • All user access is fully role managed.
  • All patient personal identifiable data is DES or AES encrypted prior to database storage.
  • User authentication service with digital signature function meets FDA and GCP requirements.
  • Fully encrypted audit trail of all user transactions.

 

 

 

 

 

 

 

Evado eConsent

Evado eConsent module enables sites to record a patient’s consent to participate in a trial, study or registry using the Evado mobile client running on a mobile device.

The consent page is prepared as a checklist. The patient confirms their consent by checking off each of the checklist items, then endorses their consent by signing their signature on the mobile device at the bottom of the page.

The completed consent record is then submitted to the Evado server, where the patient signature graphic is encrypted and saved to the database.

General users are able to see the patent consent form content and site users can also see the patient name and signature.

 

 

 

Data Collection

Evado’s data collection features replace the paper based CRF booklet with secure electronic records.

The Evado data collection approach is based on sites completing one or more records during each visit, where each record represents a form (CRF). When completed, record data can be viewed on line, or printed to PDF or hard copy and exported for data analysis.

Evado data collection module can be used to collect data for:

  • Clinical trials
  • Clinical studies
  • Device studies
  • Registry studies
  • Patient recorded observations
  • Storage of externally generated patient data.

Features include:

  • Powerful online form design tools to enable users to quickly design and build the forms they need.
  • Trials and studies can include: concomitant medications, adverse events and or serious adverse events.
  • User can edit, revise and issue form layouts on line
  • Form can be versioned without affecting previously collected study data.
  • External images and streamed videos can be included in form layouts.
  • Re-use form layouts across multiple research projects.
  • Update patient schedules to plan a patient visit.
  • Online source data monitoring and management.
  • Progressive data locking of completed records.
  • Computes the total number of data points in the trial
  • Generates the CRF booklet at the completion of the trial or study.
Medical device specific features
  • Pre-surgical data collection
  • Implant date visit scheduling.
  • Follow-up questionnaires.
  • Support for industry standard questionnaires.

Clinical research management teams can:

  • View subject records at any point in the trial or study.
  • Monitor the progress of the trial or study.
  • Sponsors can be given read only, real time access to the trial or study data.
  • Alerts and notifications when queries or adverse events are raised.
  • Preliminary online analysis of trial or registry data.
  • Data export for statistical analysis.
Online Questionnaire

The questionnaire module can collect patient follow-up questionnaires anonymously.

  • Sites select one or more patients to receive the questionnaire.
  • Questionnaires are sent out using a registered patient email address that is privacy managed.
  • Patients can open and complete the questionnaire online.
  • The completed questionnaire is added to the patient’s trial or registry data collection without disclosing the patient’s identity.
Scanned questionnaire module
  • The scanned questionnaire module can be used to scan paper based questionnaires into Evado eClinical (scheduled for release in late 2019).
  • Sites initialize the creation of the patient’s questionnaire form.
  • The patient completes the questionnaire
  • The completed questionnaire is collected and scanned and uploaded, where is added to the patient’s data collection.

Evado eClinical replaces the paper based CRF with one or more intuitive electronic form records and then:

  • Investigators fill in a form for each subject consultation.
  • Completed forms are submitted as project records.
  • Collection of ancillary records and files.
  • Investigators can review and update records.
  • Records the monitoring and data management query resolution process.
  • Records can be tagged as source data verified by monitors.
  • Data managers can review, and lock completed records.
  • Records can be combined to generate the CRF booklet that can either be printed or stored electronically.
  • Collection of concomitant medications, adverse events and serious adverse events.

 

Registries

Evado registry has been designed for:

  • medical device
  • disease progression
  • disease monitoring
  • sponsor-initiated
  • adverse event registries.

Features include:

  • Easily configured
  • Tailored environment for collecting disease registry data
  • Multiple registries and trials can be run in the same environment
  • On line design tools
  • Collect registry data on line, export data for off-line analysis.
  • Manage up to 99,000 patients in a single registry.
  • Access data via a web browser or via a mobile device
  • Strict privacy management protocols exceed Australian and International privacy laws relating to patient data.
  • Compliant with GCP ICH 6, FDA 11 standards and HIPPA compliant.
  • Adaptable for different types of registries e.g., disease progression, sponsor initiated, adverse events and medical device registries
  • Quick patient look-ups
  • Multiple users, clean data and tailored reporting requirements
  • Multiple scheduling options including visit scheduling from device implant date
  • Follow up patients with ease over weeks, months and years
  • Import of rich data such as images and sound files.
  • Support the use of Industry Questionnaires
  • External images and streamed videos can be included in form layouts.
  • Questionnaires can be completed in clinic or via a web browser using Evado’s eQuestionnaire module.
  • Patient recorded observation (ePRO) module
  • Online electronic consent module using Evado’s mobile environment
Registry reporting

Evado provide a powerful reporting module:

  • Project managers can design reporting templates. For both standard and ad-hoc reports.
  • Report templates can be used to generate operation, monitoring or data management reports.
  • Users can select and execute reports on single or multiple projects.
  • Report data can be viewed in a web browser or on a mobile device, or exported as: Html pages, or CSV files for further analysis.

 

Patient Record Observations

Evado’s Patient Recorded Observation (ePRO) module enables patients to directly enter observations and complete questionnaires for the studies, trials or registries they are participating in.

  • Privacy management:
  • Evado PRO conforms to International Quality and Health Standards and personal and patient privacy regulations.
  • Evado’s strict privacy protocols ensure that non-study sites cannot access patient personal data. All patient personal and private data is encrypted prior to storage in the database using an automated key management process. Only the patient and users at the clinic the patient is attending can view and update the patient’s person information. All other users have de-identified access patient records.

Features include:

  • Patients can access the Evado using a standard web browser or a mobile device.
  • The PRO environment is separated from the normal user environment to provide additional security.
  • Only registered patients can access the PRO environment.
  • The user access controlled using an anonymous account name and system generated password.
  • All patient personal data is fully privacy managed, including encryption of personal data prior to storage in the database.
  • The PRO can collect standardized patient records, e.g. Activity of Daily Living, or trial, study or registry specific questionnaires.
  • The PRO automatically prompts the patient to enter the next data collection record in their schedule.
  • Patients can view the data they have entered or update their personal data.
  • The Evado scheduling system can designate specific data collection points to be completed by the patients who in the trial, study or registry.
  • An Evado site can run with a mixture of PRO and non-PRO patients and staff can enter the relevant records for non-PRO patients.
  • The patient PRO consent controls data collection and sharing of PRO data with other trials, studies and registries.