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Unified data structure for metadata information in clinical analysis & reporting (A&R), leveraging the Analysis Data Model (ADaM) datasets for consistent and accurate metadata representation.


The metalite framework is designed to:

  • Standardize function input for analysis and reporting.
  • Separate analysis logic from data source.
  • Enable the use of pipes (|>).
  • Reduce manual steps to develop and maintain documentation in clinical trial development.
  • Ensure consistency between analysis specification, mock, and results.

Use cases

The metalite package offers a foundation to simplify tool development and create standard engineering workflows. 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.

Note: metalite is a low-level R package that needs to work with other R packages to complete the work. The idea is illustrated in the diagram above.

Design principles

We built metalite with the following principles:

  • Automation: prefer a function call more than a checklist.
  • Single-entry: enter in one place, sync to all deliveries.
    • For example, enter data source one time for all AE analysis.
  • End-to-end: cover all steps in software development lifecycle (SDLC) from define to delivery.