Initial Situation

Pharmaceutical companies require a statistical computing environment (SCE) for data analysis in clinical trials that meets the highest regulatory requirements in terms of data security and consistency. The largest research-based pharmaceutical company in Germany was using a central, 25-year-old SAS-based, business-critical system that needed to be replaced.

HMS Solution

HMS replaced this outdated system with a modern, cloud-native SCE.

We supported our client in several phases of the project:

• Technical proof-of-concepts, including the pioneering integration of the SCE webapp with SAS Studio using SAS-Viya as the IDE.
• Conceptual system design with regard to data storage, security and access using AWS services.
• Agile implementation of the system and simultaneous implementation of a validation strategy that simplifies regular release deployments through a high degree of automation.

Benefit

By implementing this solution, our customer benefits from

• Seamless integration of the SCE webapp with SAS Studio for efficient workflows.
• Optimised system design with AWS services for highest data security and access.
• Automated validation strategy that facilitates and accelerates regular release deployments.

Our presentation

Development of a Customised Statistical Computing Environment for Clinical Trial Data Analysis

In order to release pharmaceutical products to market, the analysis of clinical trial data and reporting of the results to medical agencies is a key prerequisite. At Boehringer Ingelheim, the SAS-based solution with a customized plug-in GUI that has been used for this process for more than 25 years shall be replaced.Boehringer Ingelheim decided to partner with HMS to develop a modern and independent Statistical Computing Environment (SCE) that shall maximize business efficiency providing a tailor-made application that perfectly fits to statistical programmer’s needs. Aiming for a scalable software solution that supports multiple computing languages, the SCE facilitates state-of-the-art AWS cloud computing technologies.In its first version, the SCE integrates with SAS Viya to supports both scenarios, the launch of parameterized SAS Studio sessions but also batch execution of many programs at once. The system is also designed to support the integration of further IDEs such as R Studio.