TrialTwin :: Trial Designer

We're in the process of building metadata-driven, end-to-end Trial Designer and Simulator.

Our goals are to have:

  • a single interface to all TrialTwin functional modules

  • allowing users to quickly define, build, load, and test studies

  • while allowing all roles across organization to "play" with studies

  • and to re-run study-level simulations at will, like a race car simulator

Manage Libraries

Metadata-driven management:

  • Libraries by therapeutic area (see CRF Library Management)

  • Strict editing, role-based access control

  • Comprehensive version control

TrialTwin - Trial Designer - Manage Libraries

Manage Forms

Form management:

  • Manage forms per library

  • Track studies using specific form

The image below shows the system pre-loaded with a series of forms defined by CDISC CDASH.

TrialTwin - Trial Designer - Manage Forms

Edit Individual Forms

Manage forms outside of an Electronic Data Capture ("EDC") system:

  • UI to create, edit, manage forms

  • EDC-agnostic

  • Visualize a form in several EDCs

TrialTwin - Trial Designer - Edit Individual Forms

Manage Studies

Centralized study management:

  • Assign to specific library version

  • Centralized control center to:

    • build

    • run User Acceptance Testing

    • perform Analysis

System will allow users to create a new study by leveraging the existing libraries, CRFs within each library, and the inter-connected Controlled Terminologies, Biomedical Concepts, and terms stored in our Data Standards Governor platform.

TrialTwin - Trial Designer - Manage Studies

Patient Journeys

Define Patient Journeys:

  • By Therapeutic Area

  • By disease

  • Or for a specific study

User will be able to either re-use pre-defined Patient Journeys and/or create study-specific Patient Journeys.

TrialTwin - Trial Designer - Patient Journeys

Build Study

Build a study:

  • Define EDC to target

  • Choose to load test data

Once a study is defined, TrialDesigner will interface with an EDC system to:

  • Build study using the metadata stored in the MDR

  • Load study-specific Synthetic Health Data (see Synthetic Health Data)

  • Run automated User Acceptance Testing ("UAT")

TrialTwin - Trial Designer - Build Study

Run User Acceptance Testing

User Acceptance Testing:

  • System runs automated UAT

  • Select browser type

  • Select target server (EDC)

TrialDesigner is designed to initially connect to Medidata RAVE.

This connection will be implemented as a "connector," allowing us to build other EDC-specific connectors.

We re-use our own internal processes to demonstrate a metadata-driven UAT of each EDC. Where TrialDesigner:

  • automatically generates test scripts for Playwright1, a web-browser automation framework

  • run tests and generate reports, validation summaries

TrialTwin - Trial Designer - Run User Acceptance Testing

Analysis Phase

Create Drafts for Analysis:

  • Dashboard

  • Annotated CRFs

  • eCRF Completion Guide

  • Case Books

  • Impact Assessment

TrialTwin - Trial Designer - Analysis Phase

Contact us

Please contact us for more details.