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Case Study

Validated R environment for analysis of clinical studies

Pharma & GxP

Initial situation

The R programming language is becoming increasingly important for pharmaceutical companies in the planning and analysis of clinical trials. Due to the wide range of modern statistical methods and the large and very active community that is constantly developing and publishing new methods, R is very attractive both technologically and professionally. However, with regard to the qualification and validation of applications required in the GxP environment, the hurdles are much higher compared to standard software. While, for example, standardized IQ/OQ (Installation Qualification / Operational Qualification) procedures for the respective operating environment are included in the scope of functions, with R a large number of dependencies on the operating system, other R packages and their versions must be taken into account for the successful execution of the unit tests supplied. It is also important to ensure that the high regulatory security requirements can be met in the day-to-day work of users.

HMS solution

The R environment was designed with three levels: While users are free to select and use R packages on the development environment, the test and production environments have been classified and validated as GxP-relevant. The definition of clearly defined and documented deployment processes ensures regulated operation: In order to install new packages or versions in the production environment, these are first evaluated in the test environment according to standardised guidelines and then transferred to the production environment as part of a change procedure. Changes to the R installation itself and the available packages are not possible in the test and production environment for standard users, but are reserved for a special user, the super user. Used packages are stored in a local repository using the miniCRAN package. In combination with the Checkpoint package, all packages are assigned to a date (date snapshot). This means that historical program executions can also be reproduced, as they are based on a defined date snapshot.

Usage

The possible replacement of previous standard software with validated R packages can reduce the cost of license fees in the future. The new platform enables the use of modern statistical methods developed by the scientific community. Users work freely exploratively and can install and test new packages in accordance with the regulatory requirements in the GxP environment.
On the road to success

Implementation

  • Technologies: R, RStudio, rpakt, Windows Server
  • Solution approach: Establishing R as a new programming language
  • Architecture: System environment with three environments (dev, test, production), Deployment-rules to further development(rollout of R-packages)
Customer: medac
medac Gesellschaft für klinische Spezialpräparate mbH is a global pharmaceutical company with a steadily growing pharmaceutical and diagnostics division. Since its foundation in 1970, medac has specialised in the indication areas of urology, oncology and autoimmune diseases. More than 1,900 employees worldwide work in the development, production and marketing of medac products. In addition to expanding the established range of medicines, medac focuses on the further and new development of needs-based therapeutics and diagnostics - always with the aim of improving patients' quality of life.
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