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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.

Use cases

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.