Revealing the true potential of your study data.
We provide a comprehensive set of biostatistical services covering all aspects of the clinical trial process. Our PhD-level experts can fulfill any biostatistical service or analysis request, across all therapeutic areas.
Our aim is to help you form better informed decisions by offering you fast, reliable, and flexible statistical service. We tailor our solutions to meet your requirements, including phase I – IV clinical trials, regulatory submissions, as well as custom calculations and reports.
Our team specializes in statistical programming, medical statistics, pharmacokinetics, and pharmacodynamics, as well as population pharmacokinetics.
- Biostatistical input into study design, trial protocol, and final CSR
- Sample size and power calculations
- Statistical consultation for CRF design
- Writing of the Statistical Analysis Plan and Statistical Analysis Report
- Interim analyses
- Statistical programming (R, SPSS, SAS) and analysis with TFL generation
- Database operations
- CDISC compliant dataset generation (SDTM, ADaM)
- Pharmacokinetics, Pharmacodynamics, and Population Pharmacokinetics
Our Team Specializes In Medical Statistics.
Determining the appropriate sample size for your study is critical to the success of your study. After all, using the wrong sample size can doom your study from the start.
We can perform sample size and power calculations for trials of any complexity. We work with you to determine what is the best solution for your study or trial.
Do not worry if your study is not the gold standard two-arm double blind, placebo-controlled trial. We have experience with all types of study designs and can provide sample size and power calculations for multi arm trials, crossover, multiple crossover designs, one arm studies, as well as for adaptive trial designs.
We can perform literature reviews to determine historical controls for one arm studies, or to suggest hypothesized effect sizes for your product.
Randomization is one of the essential processes in the design of clinical trials. It is a process of assigning patients to groups by chance, in order to prevent bias and achieve optimal patient allocation. The purpose of randomization is to produce comparable groups, which can be analyzed accordingly, with the use of probability theory and statistical models.
Our team of top-level experts is well versed in randomization procedures for various trial types and will work with you to find the best fit for your trial design.
We can tackle the complexity of substance absorption, distribution, metabolism, and elimination with top-level statistical precision. Pharmacokinetic, pharmacodynamic as well as population pharmacokinetic analyses are performed by PhD-level experts in these fields. Wemedoo AG thus ensures that these complex analyses and their reporting are performed with the care and expertise that they require.