Trial Designer
We're building a 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
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.
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
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.
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.
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")
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
Analysis Phase
Create Drafts for Analysis:
- Dashboard
- Annotated CRFs
- eCRF Completion Guide
- Case Books
- Impact Assessment