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Use of MSA Framework Enabled Improvements to Study Report Cycle Times

Featured Solution: Modernization of Statistical Analytics (MSA) Framework

Improving Internal Processes

“We’ve applied principles and concepts within TransCelerate’s ‘Modernization of Statistical Analytics (MSA) Framework‘ to improve our internal risk assessment process when it comes to using various statistical analytical tools. Our internal process to date was heavy on documentation and did not take a risk-based approach. Application of the MSA Framework helped us adopt a more risk-based approach for evaluating the ‘accuracy, reproducibility, and traceability’ of these different software environments. We gained the confidence of our quality teams to demonstrate how we can apply a more rigorous but focused approach to assessing the risk of using internal and external tools to support regulatory submissions.

The “ART Model” from the MSA Framework

Using the Framework and Implementing A New Tool

In a specific instance, we applied our MSA Framework-inspired approach to determine whether open-source packages were fit for purpose. We initially applied the approaches offered by the Framework to assess the functionality of open-source packages. By having a more robust practice to assess programming tools for accuracy, reproducibility, and traceability, we could use an open-source package to facilitate the transcription of clinical trial summaries and displays back into various Microsoft files used for reporting. We extended the package to ensure that our transcribed tables met the necessary formatting criteria for our clinical study reports. The innovation greatly saved our medical writers’ time from manual rework and helped us ensure data quality.

Overall, using this package with our medical writing teams helps us reduce our cycle times because we have eliminated the manual transcribing that the tool can now do. Being able to anchor to the Framework paved the way for the use of modernized analytical tools, and the goal is to make this tool the default setup for all studies.”

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