Statistical Computing Environment at Boehringer Ingelheim

Management Summary

HMS supported the project from technical proof-of-concepts through system design to agile implementation. The platform combines programming, batch execution, and validation into 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 integrated in the future.

Project summary

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Boehringer Ingelheim

Branche: Pharma
Projektstart: 04/2021
Schwerpunkt: Migration & Modernization
Use Case: Legacy System Modernization

Projektziel

Ablösung eines geschäftskritischen Altsystems durch eine cloud-native Statistical Computing Environment

Wichtigste Kernfunktionen

Webanwendung für die Planung, Ausführung und Validierung statistischer Programme
Integration von SAS Studio unter SAS Viya für interaktive und Batch-Ausführungen
Automatisierte Tests und Validierungsdokumentation für regelmäßige 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 continue to be supported and made expandable to meet future requirements. At the same time, the business unit, IT, and quality assurance had to coordinate their requirements regarding 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 the creation of regulatory reports.

Proof-of-Concepts and System Design

Technical proof-of-concepts established early on 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 maps the structure of a report as a work overview. Responsibilities, programs, and validation methods can be assigned to individual report elements. 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 transferred 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. Testing of functional specifications and the generation of validation documentation are integrated into the development process.

GxP Validation from the Very Beginning

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

Statistical Analysis Processes Under Control

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

Integrated

Run Programs Flexibly

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

Transparent

A Central Overview of Status

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

Understandable

Securing Program Versions

Controlled versioning documents the path to the validated program version.

Automated

Simplify Releases

Automated tests and documentation steps support regular release deployments.

Expandable

Include Additional IDEs

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

Cloud-native architecture thus provides a scalable foundation for the analysis and regulatory processing of 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 and 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, workflows, and validation must all align. To achieve this, HMS combines software engineering with expertise in SAS environments and regulated development processes.

Technical proof-of-concepts and system design for operation on AWS
Integration of SAS Viya and SAS Studio into custom applications
Automated testing and validation documentation for regular releases; selection and

Nicolai Henrichs

Principal Sales & Solutions Consultant | Partner

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Next Steps and Further Study

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