Business areas and services
Biomarkers & Translational Data Science
Providing in-depth expertise for Precision Medicine.
Clinical Data Science
Biomarkers & Translational Data Science
Data Transparency and Medical Writing
An important challenge in future drug development is “Precision Medicine”, which provides targeted solutions tailored to individual patients.
Translational medicine plays a key role in the biomarker guided recommendation of suited therapies.
It combines knowledge from basic research with advanced statistical methods with the goal of identifying patient populations that are more likely to benefit from a therapy or that will show fewer side effects.
Biomarkers
We support clients across all study phases and indications, with a particular strength in oncology. Our focus is on translating complex biomarker questions into precise, usable insights that advance precision medicine.
We deliver end-to-end biomarker work packages including:
- Statistical consulting throughout the biomarker workflow
- Input to protocols and SAPs, including precise specification of biomarker analyses and sample size calculations
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Application of innovative study designs tailored to biomarker objectives
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Visualisation and analyses of complex, high-throughput biomarker data
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Identification and validation of biomarkers using complex statistical models
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TLF generation in R and SAS, including reusable programs and high‑quality reporting outputs
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Cross‑functional collaboration with clinical, translational, and regulatory teams
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Regulatory‑ready documentation, including consistent and transparent reporting of biomarker methods and results
Main Expertise:
- Advanced statistical methodology, including machine learning and causal inference
- Identification of predictive and prognostic biomarkers
- Cutoff determination and development of biomarker signatures
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Pharmacodynamic analyses and proof‑of‑mechanism for early‑phase decision‑making
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Experience with regulatory submissions and alignment with relevant guidelines
Bioinformatics
Our bioinformatics team builds programming solutions tailored to biomarker research and data-driven decision-making: From early study design through final delivery. We work across a broad range of biological and clinical data sources to produce analysis-ready datasets, statistical outputs, and customised reports that fit the study objectives and predefined analysis plans.
A core part of our work is omics data analysis, covering genomics, transcriptomics, proteomics, and other high-dimensional biological data. We combine bioinformatics methodology with solid programming and data integration to surface meaningful biological insights, identify potential biomarkers, and support patient stratification.
Quality, reproducibility, and regulatory compliance are built into every step of the process. Finalised datasets and outputs go through thorough review before being handed over to statisticians, programmers, and data managers, so the results are well-documented and ready to use with confidence.
Main Expertise:
- Transcriptomics: Single/bulk RNA-Seq data (pre-) processing, differential expression analysis, and gene ontology enrichment.
- Genomic Data Analysis: Sequence alignment, variant calling, and population genomics.
- Proteomics and Metabolomics: Integration of proteomics and metabolomics data to identify and understand regulation patterns and metabolic pathways.
- Documentation and Analysis Services: Specification and review of bioinformatics analyses in statistical analysis plans (SAP), as well as the writing and input for data analysis sections.
- Transcriptomics Pipeline Support: Comprehensive support for customers looking to develop their own transcriptomics pipelines.
Guidance on setting up raw data preprocessing using Nextflow, snakemake, containerization technologies, and best practices for creating efficient and reproducible workflows.
Diagnostics
During the development of new diagnostic products, it is necessary to provide regulatory authorities or Notified Bodies with data on the analytical properties of the product (e.g. precision and accuracy), as well as its clinical performance (sensitivity and specificity).
We provide biostatistics services to assemble, analyse, and report the required tables and figures in this context. Medical devices include a wide range of devices intended to be used for medical purpose.
We provide statistical services during the development and market approval process of such devices accordingly.
Diagnostics Assay Development and Medical Device Services:
- Statistical and analysis planning for medical device, and diagnostic assay trials
- SAP writing
- Statistical programming
- Report writing
CMC & Non-Clinical Statistics
In non-clinical/CMC statistics the reproducible quality of drug products is evaluated using descriptive as well as more elaborate statistical approached. Furthermore, design-of-experiment (DoE) approaches are used to find optimal conditions to manufacture complex drug products.
The underlying data in non-clinical statistics is usually centred around the properties of the drug product (e.g. how the product dissolves in a liquid, the biological activity in a test tube rather than in a patient). Our work in this domain contrasts with that for Phase 1-4 clinical trials where we study the safety and efficacy of drugs in patients.
Main Services:
- Statistical consulting in CMC and non-clinical statistics projects
- Stability testing, analytical validation, linearity, accuracy and reproducibility assessments, and comparability exercises
- Justification of specification
- Design of experiments, statistical input and recommendations
- Planning, consulting, programming, reporting
Ready to Collaborate?
Whether you need senior biostatistics support, reliable data science expertise, or strategic guidance for your clinical development programs, our team is here to help.