Statistical Programming

Statistical Programming

We understand that efficient statistical programming requires seamless collaboration across multiple disciplines by working closely with data management and statistics. Our commitment to technical expertise in related disciplines ensures efficient and adequate data processing in the clinical trial analysis. Our team has extensive experience of working with well-established industry standards, such as CDISC SDTM and ADaM, as well as emerging approaches, such as those found in precision medicine.

Early Development Statistics

Early Development Statistics

Preclinical Statistics - Focus on the Animal
Preclinical Statistics covers the early non-clinical phases of drug development. We support our scientific partners in both, basic research and preclinical studies. We also work with marketed medicines, for example in toxicology and safety pharmacology or when investigating new mechanisms of action. These studies are mainly animal-based and in vitro.

Phase I/ IIa Statistics - Focus on the Human Being
In Phase I/ IIa clinical trials, we provide support in the evaluation of pharmacokinetics, tolerability, and safety of the drug, as well as in the proof of concept evaluation. We accompany the studies, from the planning and preparation of statistical evaluations to the publication of the results.

Biometrics & Diagnostics

Biometrics & Diagnostics

Statistical service for researchers and scientists
We accompany every phase of scientific projects, from planning to evaluation and publication.

Real World Evidence - Real data, concrete results
Real World Evidence (RWE) demonstrates potential benefits or possible risks of medicines based on Real World Data (RWD) generated in clinical practice outside traditional trials. We clarify the safety, efficacy, and cost-effectiveness of drugs and medical devices. In this way, we help develop better therapies and prove their value.

Diagnostics - Personalized health care, the next generation of healthcare
Early and accurate diagnosis is integral to decision-making along a patient's entire health or disease trajectory. Medical treatments are increasingly tailored to the unique needs of individuals or smaller groups of patients. We assist in the further development and control of in vitro diagnostics and the evaluation of laboratory measurements.

Statistical service for researchers and scientists We accompany every phase of scientific projects, from planning to evaluation and publication.

Medical Affairs Statistics

Medical Affairs Statistics

Communication is our strength
In the area of Medical Affairs, our analyses help to better understand the drug in order to provide relevant information to medical doctors and patients. We answer medical questions that are of interest to various functions in the healthcare system. How well does the drug work compared to other therapies? In which patient subgroups do side effects occur frequently? What is the impact of the treatment on quality of life? Could the drug be used for other indications? 

We help our clients generate new knowledge and expand existing knowledge. The comprehensive communication and presentation of data is the key to making medical content accessible to medical professionals and patients on an interdisciplinary basis. This way treatment strategies for patients can be continuously optimized - this is dear to us.

Late Development Statistics

Late Development
Statistics

We accompany clinical studies from dose finding to approval and beyond. In addition to investigating the efficacy of a drug, we also focus on examining the safety and providing support in evaluating the benefit-risk ratio. We take over the organization and planning of the statistical aspects of a study or advise on specific statistical questions.

Health Technology Assessment

Health Technology Assessment

The last vital step to improving patient healthcare: the systematic and evidence-based evaluation of new medical procedures and technologies. For the requirements in the field of HTA, we rely on the combination of statistical methodological expertise and programming experience.

AMNOG process in Germany
We support the AMNOG process with our broad knowledge in the preparation of dossiers in the role of a HTA statistician. We take care of all statistical aspects of the benefit assessment. We also carry out the necessary additional analyses in accordance with the requirements of the G-BA and IQWiG.

EU HTA
The EU HTA Regulation came into force on January 1, 2025. We support you in this European process with our many years of experience from the AMNOG process.

Biomarker Statistics & Data Science

Biomarker Statistics
& Data Science

Biomarker Analyses
Biomarkers serve as a tool for diagnosing a disease, monitoring the course or the success of the therapy, as a surrogate endpoint of a clinical trial, or as a basis for developing personalized therapies.
The resulting, often large and high-dimensional data sets, and the processing of individual and explorative questions are the challenges in biomarker statistics. Our experienced team from biostatistics and data science provides support from planning the analysis, programming, and evaluation to the interdisciplinary communication and scientific publication of the results.

Data Science
We support the processing, exploratory analysis, and visualization of data of any type, drawing on our diverse experience in classical statistics and machine-learning methods.
If recurring tasks are involved, we offer the possibility of a generalized solution. We develop individual and professional tools such as pipelines for documented and reproducible data analysis with automated reporting or web apps for interactive data visualization and presentation. We provide these tools in the form of R packages, taking advantage of the diverse capabilities of R Markdown and Shiny, among others.