Management Summary
BioHorizons Camlog, a leading provider of premium dental implant systems, has partnered with HMS to leverage a diverse range of cutting-edge technologies to successfully integrate and streamline disparate datasets. A robust data warehouse and Power BI model now enable efficient and reliable reporting. This innovative solution ensures scalable, high-performance data integration and has also enhanced analytical capabilities, enabling global data-driven decision-making.
Project summary
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
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 snapshots
Tech Stack
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 technical and methodological perspective.
However, when it comes to the qualification and validation of applications required in the GxP environment, the requirements are significantly higher than for standard software. While standard software comes with corresponding IQ/OQ procedures for Installation Qualification and Operational Qualification, numerous dependencies must be considered when validating R and its packages. 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 requirements are met in day-to-day operations.
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.
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