Taking a Modern Approach

In order to modernize their approaches, organizations have recently been turning to consortia like Transcelerate Biopharma, in addition to stalwarts like CDISC. Transcelerate’s Modernization of Statistical Analytics Framework2 aims to increase the use of modern statistical analysis technologies within the industry, enabling the faster delivery of innovative treatments to patients. Within this framework, three core principles for regulatory compliance are identified as follows:3

1

Accuracy

The measure of correctness of software libraries that are used to generate results from a modern statistical analytics environment 2

Reproducibility

The ability to recreate statistical analysis outputs from the original dataset along with the associated environment, including all artifacts and dependencies 3

Traceability

The ability to trace inputs to outputs, providing evidence to connect e-data, code, and environment to the final output that is produced

Leveraging a Statistical Computing Environment with the key capabilities and functionality outlined below will ensure your organization is in line with digital approaches. Modern SCEs can make sure that these three principles of regulatory compliance will be met, while increasing development efficiency and streamlining program execution.

Program Development

■ Full version control and access management ■ Development lifecycle workflows

■ Customizable folder structure within and accross studies

■ Library of reusable code snippets, macros, and functions

■ Intelligent editor with auto-complete and automation of common taskes Execution

■ Integrated compute environments for SAS,

R, and Python ■ Support for package/ library validation ■ Interactive real-time results or scheduled batch execution

■ Log checking and display of results ■ Full audit trail and reproducibility of results Automation

■ Dependency tracking for both data and inherited code

■ Automated execution of programs based on data refresh

■ Impact analysis and notification of data structural changes ■ Auto-creation of programs based on configurable templates ■ Data flow visualization from source output