Incorporating Media into a Trial or Study Protocol

Incorporation of multi-media in a trial protocol to capture required assessments and document outcomes can make a significant impact in demonstrating the clinical meaningful effect of treatment. Mobile technology, with vastly enhanced security and media capture capabilities, is ideal to provide these features, including capability to attach custom data fields to any specific timepoint(s) of a video file. Using the ANZU® patented video bookmarking technology, this process is integrated with the EDC, requiring no additional vendors, websites, or separate logins.

The media component of the EDC can be broken into four features, accessible to the end-user based on their designated role in the study:

Media Capture

Design and Record Protocol-Based Qualitative Events

Role based access to any recording feature or combination of features

  • Videos
  • Image
  • Audios

Customized data fields or forms associated with media files

Optimized, encrypted, rapid video packet upload directly to secure cloud infrastructure

Direct upload to Media Assessment Workflow for further processing

Record Videos or Audio, Take Photos

Configure Video Resolution

Media Assessment

Quantifying Qualitative Information

Patented bookmarking of protocol-defined data fields in a recorded patient evaluation

  • Videos
  • Audios

Patient/Parent shared videos available for review/assessment if defined in protocol

Role based access

Filterable data sets

  • Site
  • Subject
  • Visit
  • Evaluation
  • Data Field
  • Media Type

Direct submission to Media Validation/Review Workflow for further processing

Media Validation/Review

Expert Assessment and Review

Single reviewer or sequential multi-reviewer workflows based on trial/study protocol

Form based evaluation of photos

Role based access defines reviewer functionality

Variable functionality in the reviewing process

  • Approve assessment
  • Reject assessment
  • Add assessment
  • Edit assessment

Reviewer can message Study Manager/Reviewers/Site personnel

Direct submission to Sponsor Trial/Study Media Library

Sponsor Trial/Study Media Library

Tracking Your Trial Patients’ Progress Through Multi-Media Analysis

View all media that has completed the review process

Role based access

Filter Media Library by:

  • Media Type
  • Site
  • Subject
  • Visit
  • Evaluation
  • Data Field (for video and audio)
  • Datapoints on photo evaluation form

Create ”Video Playlist” based on filtered dataset and export as an mp4 video (optional)

Create a “Photo Playlist” based on a filtered dataset and export as a PowerPoint (optional)