Statistical Computing Environment at Boehringer Ingelheim

Management Summary

HMS supported the project from technical proofs of concept and system design through to agile implementation. The platform combines programming, batch execution, and validation in a traceable workflow and complies with GxP requirements for data storage, access control, and validation. Automated tests and documentation steps simplify regular releases. Additional development environments can be added in the future.

Project summary

#lifesciences

Boehringer Ingelheim

Industry: Pharmaceuticals
Project Start: 04/2021
Focus: Migration & Modernization
Use Case: Legacy System Modernization

Project Goal

Replacement of a business-critical legacy system with a cloud-native statistical computing environment

Key Core Functions

Web application for planning, executing, and validating statistical programs
Integration of SAS Studio with SAS Viya for interactive and batch executions
Automated testing and validation documentation for regular releases

Tech Stack

angular aws lambda sas viya

The main challenge was to combine agile development and GxP validation in a way that reliably supports regular releases.
Dr. Christoph Frank
Senior Project Lead

The Starting Point

Statistical programmers generate regulatory reports based on clinical trial data. The existing central SAS system had been supporting this business-critical process for 25 years. Teams that analyze clinical trial data worked with established workflows and had high requirements for data consistency, access control, and traceability.

A replacement therefore had to do more than simply involve a technical platform change. The existing workflows needed to be retained while allowing for future extensions. At the same time, the business unit, IT, and quality assurance had to align their requirements for system design, validation, and release processes.

Mitarbeiterin arbeitet am Laptop an der Analyse klinischer Studiendaten.

The HMS Solution

SCE on AWS with SAS Viya Integration

HMS collaborated with Boehringer Ingelheim to develop a customized statistical computing environment for producing regulatory reports.

Proof-of-Concepts and System Design

Technical proofs of concept were used early in the project to determine how the SCE web application could be integrated with SAS Studio under SAS Viya. Building on this, HMS designed the data storage architecture as well as the security and access concepts for operation on AWS.

Integrated Development and Execution Processes

The web application provides a structured overview of the report and the associated work. Responsibilities, programs, and validation methods can be assigned to individual elements of a report. Parameterized SAS Studio sessions as well as sequential and parallel batch executions are controlled from within the application. Scheduled executions were planned as an extension.

Secure Versioning and Results Processing

Program versions are moved from the development environment to a read-only area in Amazon S3. The application displays execution status, errors, warnings, and missing log files. Results can be consolidated into PDF documents for regulatory reports.

Validation in the Development Process

HMS combined agile implementation with a validation strategy focused on automation. The OpenDevStack Framework supports the creation, testing, documentation, and deployment of the application. Tests based on functional specifications and the generation of validation documentation are integrated into the development process.

GxP Validation from the Start

HMS developed the validation strategy in parallel with the application. System and software design, risk analysis, testing, and documentation were directly integrated with development and deployment.

Automated testing and validation documentation support regular releases in accordance with GxP requirements.

Customer Benefits

A Controlled Statistical Analysis Process

The new environment combines programming, execution, and validation into a single workflow.

Integrated

Flexible Program Execution

SAS programs can be developed interactively and executed individually or in batches.

Transparent

A Central View of Project Status

Project teams can view the implementation and validation status in a single interface.

Traceable

Controlled Program Versioning

Controlled versioning documents the path to the validated program version.

Automated

Streamlined Releases

Automated tests and documentation steps support regular release deployments.

Extensible

Integrate Additional Development Environments

The architecture is designed to accommodate the future integration of additional development environments, such as RStudio.

The cloud-native architecture provides a scalable foundation for the analysis and regulatory reporting based on clinical trial data.

Presentation on the Statistical Computing Environment

Request the presentation now

Boehringer Ingelheim and HMS presented the development of the SCE at PHUSE EU Connect 2024. The presentation, titled “Development of a Customized Statistical Computing Environment for Clinical Trial Data Analysis,” covers the technical workflows, the integration of SAS Viya, the system architecture, and the approach to continuous validation.

Our Strengths, Your Benefits

Combining Cloud-Native Development with GxP Validation

HMS supported Boehringer Ingelheim in replacing a 25-year-old SAS system. In this project, we combined AWS architecture, SAS Viya integration, and agile software development with an automated validation strategy.

What You Can Expect from HMS

In a statistical computing environment, cloud architecture, development workflows, and validation need to work together. To achieve this, HMS combines software engineering with expertise in SAS environments and software development in regulated environments.

Technical proof-of-concepts and system design for operation on AWS
Integration of SAS Viya and SAS Studio into custom applications
Automated tests and documentation steps support regular release deployments

Nicolai Henrichs

Principal Sales & Solutions Consultant | Partner

Are you planning a similar project?

Talk to us about your current situation and the requirements for a potential implementation. We’ll help you assess the project from a business and technical perspective and determine the best next steps.

Discuss the project

Related Services oder Explore Further

Migration & Modernization

Learn how HMS modernizes legacy applications and data platforms in phases, supports migrations, and aligns technical changes with the requirements of ongoing operations.

Clinical Data Management and Analytics

HMS provides support for the preparation and analysis of clinical data as a basis for statistical evaluations and advanced machine learning applications.

Learn more about Clinical Data Management and Analytics

Cloud-Native Statistical Computing Environment for Clinical Trials