Good Statistical Monitoring (gsm) R package

Good Statistical Monitoring (gsm) R package implements end-to-end statistical analyses of key risks to support risk-based quality management in clinical trials.

Key Features:

• Data Mapping: Supports mapping of clinical trial data from a variety of formats.
• Risk Indicator Evaluation: Evaluates 12 key risk indicators.
• Interactive Visualization: Provides interactive visualization of analysis results.
• Standardized Reporting: Creates standardized reports with results exportable to other clinical systems.
• Modular Workflow: Employs a modular workflow where any component can be replaced with a study-specific alternative.

Scientific Applications:

• Risk-Based Monitoring: Detects potential risks to critical data and processes earlier in clinical trials.
• Proactive Risk Mitigation: Facilitates follow-up risk mitigation through interactive reporting for clinical study teams.

Methodology:

The package uses a modular workflow for risk assessments with rigorous testing and qualification performed as part of each release.