The purpose of metalite
is to define a unified data structure to save metadata information
for analysis & reporting (A&R) based on ADaM datasets in clinical trial development.
The R package is designed to
- standardize function input for analysis and reporting.
- separate logic from data dependency.
- enables pipes (
|>
). - reduce manual steps to maintain SDLC documentation.
- ensure consistency between analysis specification, mock, and results.
We build metalite
to enable principals below:
- Automation: a function call is better than a checklist.
- Single-entry: enter in one place, sync to all deliveries.
- e.g., Enter data source one time for all AE analysis.
- End-to-end: cover all steps in software development lifecycle from define to delivery.
metalite
build a foundation to simplify tool development.
For example, metalite
can be used to:
- standardize input and output for A&R functions.
- create analysis and reporting planning grid
- create mock table
- create and validate A&R results
- trace analysis records
metalite
needs to work with other R packages to complete the work.
We illustrate the idea in the diagram below.