Modernization of Statistical Analytics Solutions

This Framework is based upon a methodology that establishes the principles of accuracy, reproducibility, and traceability for a modern analytical software environment to demonstrate that the results it generates is reliable. A set of best practices and guiding principles is also provided to support the Framework’s implementation across industry sponsors and other stakeholders. Click here to download. 

Provides a visual overview of the MSA Framework including key methodologies, concepts, and impact areas for a broader understanding of the Framework paper. Click here to download.

A presentation to support the socialization and usage of the framework concepts. This deck aims to help organizations better understand and utilize the MSA Framework as they explore the use of nontraditional analytical software in clinical research. Click here to download.

Each presentation guides the viewer through a case study scenario that focuses on how the framework was applied in that implementation example and the lessons learned around the benefits, challenges and efficiencies during the implementation process.

Asset Type	Title	Description	Phase of Framework Implementation
	Case Study 1: Interactive Collection of Analysis Tools (Video & Presentation)	A collection of interactive and static analysis tools enabling faster and more efficient exploratory analysis and regulatory delivery of clinical trials insights.	Production
	Case Study 2: Environment for Regulatory Submission (Video & Presentation)	Multi-server computational environment that contains two different types of open source installations – usual installations for exploratory and general work and frozen installations for submission related work.	Production (Note: with ongoing loops between design and implementation with platform evolution)
	Case Study 3: Group Sequential Design (Video & Presentation)	Study design for group sequential studies to expand and enable the universe of ‘increasingly compliant’ tools with increasing capabilities.	Production (Note: with ongoing loops between design and implementation with platform evolution)
	Case Study 4: Testing/Verification (Video & Presentation)	Offers guidance on providing a secure and reliable environment for both exploratory and submission related analyses using open-source products.	Production
	Case Study 5: Implementation and Validation Concept (Video & Presentation)	Explains digital transformation requirements for integrating reports into standard reporting system to create transparency.	Pre-Planning
	Case Study 6: Using the Framework to Improve Package Validation Process (Video & Presentation)	Lessons learned during building a process to use suitable digital solutions for Digital transformation and integrability, Data analysis and Reporting.	Production