Leading diagnostics company in the field of in-vitro diagnostics
Highlights
Automated and standardized statistical reporting for tables, listings and graphics
Scalable, validated R package developed for high regulatory compliance
Seamless integration into Roche’s existing biostatistics workflows
Technology stack
R
testthat
rmarkdown
Agile V-model
„
We built a validated R package for Roche’s clinical reporting – reducing manual coding while ensuring regulatory compliance at every step.
“
Dr. Dorothee Childs
Senior Data Scientist
Talk to our experts
Roche Diagnostics operates in a highly regulated environment, where statistical reporting for performance studies must meet stringent accuracy and compliance standards. Maintaining these requirements through manual processes is resource-intensive and time-consuming.
Before the development of TLGcat, Roche recognized increasing complexity in study reporting and the need to maintain strict regulatory compliance. Manual implementation and validation of reports required valuable time and resources, making efficiency improvements a priority.
To address these demands, Roche initiated a strategic effort to enhance consistency, automate analyses and strengthen collaboration to accurately meet FDA and EMA standards.
The HMS Solution: A Validated R Package for Clinical Reporting
Automated Reporting with TLGcat
Roche partnered with HMS Analytical Software to develop TLGcat, a validated R package tailored for efficient and compliant statistical reporting in performance studies
The solution offers:
Standardized statistical analyses by providing predefined functions for precision analyses, reference ranges evaluations, and qualitative method comparisons
Automated report generation, minimizing manual formatting and ensuring consistent outputs
Built-in regulatory compliance through Computerized Systems Validation including comprehensive testing and documentation
Agile development principles, combining statistical expertise with professional software engineering
The result is a scalable, reliable, and compliant solution for the demands of clinical performance study reporting.
Technologies Powering TLGcat
The development of TLGcat leveraged industry-leading statistical computing and validation tools.
Programming language: R, providing flexibility and power for statistical analyses.
Testing frameworks: testthat and rmarkdown, supporting robust testing and automated reporting.
Regulatory documentation: Aligned with Roche’s internal quality management standards to meet compliance requirements.
Software development methodology: Agile V-model, combining iterative development with rigorous validation processes.
Our validated reporting package helps Roche deliver high-quality, compliant study outputs faster while meeting today’s regulatory requirements with confidence.
By implementing TLGcat, Roche strengthened their ability to meet stringent regulatory and quality standards for study reporting.
The solution delivers:
Automated and standardized reporting, ensuring consistent, validated outputs for Tables, Listings, and Graphics (TLG)
Significant efficiency gains, minimizing manual effort for comprehensive statistical evaluations, including full precision analyses (covering repeatability, intermediate precision, and reproducibility) as well as qualitative method comparisons.
Accelerated regulatory submissions, with outputs aligned to the requirements by regulatory bodies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) for efficient reviews
Robust quality assurance, supported by built-in automated testing and documentation ensuring reliable and auditable results
Seamless integration into Roche’s existing processes, enabling effective collaboration across biostatistics and regulatory teams
Overall, the solution enhances competitiveness and significantly reduces the workload for employees.
Automated Clinical Reporting: 80% Less Effort with Validated R Package
The implementation of TLGcat has led to:
Up to 80% less programming effort, with tasks previously requiring ~1,500 lines of code now accomplishable with just ~50 lines
Shorter reporting timelines, with automated workflows that accelerate regulatory submissions
Enhanced consistency of results by dedicated package modules for efficient statistical reporting
Next Steps: Roche plans to expand the use of TLGcat to additional diagnostic assays and prepare the package for a public release.
Our Strengths, Your Advantage – Automating Clinical Study Outputs
Together with Roche, HMS developed a validated reporting package that supports strict regulatory standards while improving delivery speed and consistency.
Trusted collaboration in highly regulated environments
Proven validation workflows and documentation
Agile, audit-proof development in regulated domains
Ensure compliance & reliability in clinical reporting – let’s discuss how our solutions to produce and use validated R packages can support you.
