Validated R Environment for Clinical Trials

Management Summary

To support the planning and analysis of clinical trials, HMS designed a three-tier R environment for development, testing, and production. The test and production environments were validated in accordance with GxP requirements. Defined deployment and change processes enable the controlled deployment of new R packages.

Project summary

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medac Gesellschaft für klinische Spezialpräparate mbH

Industry: Pharmaceuticals and Clinical Research
Project Start: 07/2020
Focus: Migration & Modernization
Use Case: Architecture & Technology Renewal

Project Goal

Establish R as an additional programming language under GxP requirements

Overview of the key project aspects:

Three-tier system environment for development, testing, and production
Documented deployment and change processes for R packages
Local package repository with defined file snapshots

Tech Stack

r microsoft windows server rstudio

The Starting Point

For pharmaceutical companies, the R programming language is becoming increasingly important in the planning and analysis of clinical trials. The wide range of modern statistical methods available and the large, active community that is constantly developing and publishing new methods make R attractive from both a technological and a professional standpoint.

However, when it comes to the qualification and validation of applications required in the GxP environment, the hurdles are significantly higher compared to standard software. While standard software comes with corresponding IQ/OQ procedures for Installation Qualification and Operational Qualification, numerous dependencies must be taken into account when using R to successfully run the included unit tests. These include the operating system as well as other R packages and their versions. In addition, it was necessary to ensure that the stringent regulatory safety requirements are met in day-to-day operations.

Zwei Projektmitarbeitende im Fachgespräch zur Umsetzung einer GxP-konformen R-Umgebung

The HMS Solution

Three Environments for the Controlled Use of R

HMS designed a three-tier R environment consisting of a development environment as well as validated test and production environments. Defined deployment processes and access permissions form the basis for validated operation in a GxP environment.

Separate Development, Testing, and Production

While users are free to select and use R packages in the development environment, the test and production environments have been classified as GxP-relevant and validated accordingly.

Controlled Deployment of New Packages

Defining clearly defined and documented deployment processes ensures smooth operations: To install new packages or package versions in the production environment, they are first evaluated in the test environment according to standardized guidelines and then transferred to the production environment as part of a change request.

Clearly Define Changes

Changes to the R installation itself and to the available packages are not permitted for standard users in the test and production environments; these actions are reserved for a special user, the SuperUser.

Customer Benefits

Controlled Use of Modern Statistical Methods in a GxP Environment

The key benefits of the new R environment are summarized in the following three areas.

Costs

License costs reduced

Replacing the existing software reduced the costs associated with licensing fees for standard software (e.g., SAS® and EAST®).

Methods

Modern Statistical Methods

The new platform enables the use of modern statistical methods developed by the scientific community.

How It Works

Working in an exploratory manner and testing new packages

Users can work freely and explore the system, and—in accordance with regulatory requirements in the GxP environment—install and test new packages.

Our Strengths, Your Benefits

R Expertise for Regulated Environments

In this project, HMS combined statistical programming with system architecture and requirements from the GxP environment. The solution approach treats development, validation, controlled changes, and subsequent operation as a single, integrated process.

What You Can Expect from HMS

Experience with statistical systems for clinical trials
Combining R expertise and computer system validation
Architecture and processes for controlled system changes

Nicolai Henrichs

Principal Sales & Solutions Consultant | Partner

Sie planen ein vergleichbares Vorhaben?

Sprechen Sie mit uns über Ihre Ausgangssituation und die Anforderungen an eine mögliche Umsetzung. Wir helfen Ihnen, das Vorhaben fachlich und technisch einzuordnen und sinnvolle nächste Schritte festzulegen.

Projekt besprechen

Next Steps and Further Study