Fully Integrated Mobile and Web Solutions for Clinical Trials and Studies

Paired, fully integrated native mobile (IOS and Android) and web-based applications, designed for all participants in a clinical trial or study. Workflows and user experience have been optimized for efficiency by co-designing with top clinical operations experts with decades of experience executing trials.

Features include:

  • Fully configurable role-based access to functionality and data
  • User access to multiple trials/studies with one log-in
  • Full EDC capabilities on web and mobile
  • Media capture analysis and review for videos, images, and audio
  • Communications portal (messaging) between sponsor users
  • Study specific document library
  • HIPAA compliant
  • CFR 21 part 11 compliant

Mobile and Web Apps for Management

Features

  • Study Start-Up Dashboard
  • Enrollment Dashboard
  • EDC Review/Status
    • Query Status
    • SDV Status
    • SAE Review/Status
    • AESI Review/Status
  • Protocol Deviation Review/Status
  • Safety Reports Review
  • Document Library (View/Upload)
  • Media Library (View/Create Playlist)
  • Data Administration
    • Data Listings
    • Data Reports

Mobile and Web Apps for Clinical Operations

 

Customizable Role-Based Access

  • CRA
  • CTM
  • DM
  • Medical Coder
  • Media Reviewer

Role-Based Functionality

  • Query Management
  • Adverse Event Management
  • Protocol Deviation Management
  • Media Assessor
  • Media Validate/Review
  • Document Library (View Only)
  • Document Library Upload/Manage
  • Medical Coding
  • Data Administrations
    • Data Listing
    • Data Reports

Mobile and Web Apps for Site

 

Role-Based Access

  • PI
  • Sub PI
  • CRC
  • Ancillary Personnel (Therapists)

Role-Based Functionality

  • Subject Registration/Management
  • Subject Messaging
  • Data Entry
  • Query Management
  • Adverse Event Reporting
    • AE
    • SAE/AESI
  • Media Library (View only)
  • Media Capture
  • Media Assessor (Therapist)
  • Document Library (View Only)
  • Sign Casebooks
  • Sign Safety Reports
  • eIC Management
  • eIC Video Conference
  • Training Assignments

ePRO: Mobile and Web Apps for Patients/Legal Guardians

 

eIC

  • Review/Sign
  • Video Conference with Site regarding Informed Consent

Share Media to Site (Based on Protocol)

  • Videos
  • Images
  • Audio

Document Library (View Only)

Data Entry for Study/Trial

  • Surveys/Questionnaires
  • Diaries
  • Forms

Site Messaging

ePRO: Mobile and Web Apps for Patients/Legal Guardians

 

eIC

  • Review/Sign
  • Video Conference with Site regarding Informed Consent

Share Media to Site (Based on Protocol)

  • Videos
  • Images
  • Audio

Document Library (View Only)

Data Entry for Study/Trial

  • Surveys/Questionnaires
  • Diaries
  • Forms

Site Messaging

Mobile and Web Apps for Site

 

Role-Based Access

  • PI
  • Sub PI
  • CRC
  • Ancillary Personnel (Therapists)

Role-Based Functionality

  • Subject Registration/Management
  • Subject Messaging
  • Data Entry
  • Query Management
  • Adverse Event Reporting
    • AE
    • SAE/AESI
  • Media Library (View only)
  • Media Capture
  • Media Assessor (Therapist)
  • Document Library (View Only)
  • Sign Casebooks
  • Sign Safety Reports
  • eIC Management
  • eIC Video Conference
  • Training Assignments

ePRO: Mobile and Web Apps for Patients/Legal Guardians

 

eIC

  • Review/Sign
  • Video Conference with Site regarding Informed Consent

Share Media to Site (Based on Protocol)

  • Videos
  • Images
  • Audio

Document Library (View Only)

Data Entry for Study/Trial

  • Surveys/Questionnaires
  • Diaries
  • Forms

Site Messaging

Mobile and Web Apps for Clinical Operations

 

Customizable Role-Based Access

  • CRA
  • CTM
  • DM
  • Medical Coder
  • Media Reviewer

Role-Based Functionality

  • Query Management
  • Adverse Event Management
  • Protocol Deviation Management
  • Media Assessor
  • Media Validate/Review
  • Document Library (View Only)
  • Document Library Upload/Manage
  • Medical Coding
  • Data Administrations
    • Data Listing
    • Data Reports

Mobile and Web Apps for Site

 

Role-Based Access

  • PI
  • Sub PI
  • CRC
  • Ancillary Personnel (Therapists)

Role-Based Functionality

  • Subject Registration/Management
  • Subject Messaging
  • Data Entry
  • Query Management
  • Adverse Event Reporting
    • AE
    • SAE/AESI
  • Media Library (View only)
  • Media Capture
  • Media Assessor (Therapist)
  • Document Library (View Only)
  • Sign Casebooks
  • Sign Safety Reports
  • eIC Management
  • eIC Video Conference
  • Training Assignments

ePRO: Mobile and Web Apps for Patients/Legal Guardians

 

eIC

  • Review/Sign
  • Video Conference with Site regarding Informed Consent

Share Media to Site (Based on Protocol)

  • Videos
  • Images
  • Audio

Document Library (View Only)

Data Entry for Study/Trial

  • Surveys/Questionnaires
  • Diaries
  • Forms

Site Messaging