Late Development Statistics

Late Development Statistics

Statistical competence in finding the right dosage in the observational study

Our team of experts supports you in the initial planning of the study design and the interpretation of statistical analyses. Validations and quality checks avoid unnecessary corrections and ensure accurate results. We assist you in establishing standard documents and programs, which enable you to produce the highest quality and efficient analyses for your project.

In the area of planning we support you in the preparation and quality control of relevant study documents, e. g. protocols, statistical analysis plans and clinical study reports. We estimate the sample size and prepare randomization listings. Our team develops and validates (standard) programs and macros in SAS/ R for the creation of tables, figures and datasets. Moreover, we provide statistical support regarding the preparation and conduct of study related committees (e.g. Data Monitoring Committee, Steering Committee) as well as support concerning queries in submission and approval processes from agencies (FDA, EMA, BfArM).

We assist you in the preparation and analysis of pooled study data and meta-analysis. In addition to this, we take over the intermittent preparation of reports for drug safety.

Apart from doing the preparation and interpretation of statistical reports, we support you in the process of publishing your study results in scientific journals or at conferences.

Based on our long-term experience in the area of integrated analyses we can support your project with excellent expertise for data pooling in multible studies. Additional and current information on the safety and efficacy of your medical products are therefore available in a reliable and timely manner. This helps you to respond quickly to questions during the submission process. After a successful market launch, our experienced team will assist you in the planning, conducting and analysis of non-interventional studies to further assess the safety and efficacy of your product in clinical practice.

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Not only performance and service are just right, but above all the quality.

Please contact us, we would be delighted to give you some personal advice.