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Statistic Data Evaluation


Statistical Evaluation

Regardless of whether one's requirement is clinical studies of phases I to IV, data collection in the drug application research or drug epidemiology, or analyses from existing data sets - we will find the answers to your questions in the field of statistics.

Analysis of existing data
Study concept
Study protocoll / SAP
Support of the study conduct
Performance of the statistical analysis

Special requirements and complex statistics

In a complex world of regulatory requirements and study-specific approaches, we endeavor to provide solutions that work, even for special situations. The scenarios here range from adaptive study designs to complex evaluation approaches. According to our corporate values, this service also includes the open and comprehensively supervised integration of external expertise, in particular through cooperation with our long-standing partners.

Pharmacokinetic evaluation

Our long-standing pharmacokinetic expertise is already incorporated into study planning - our staff have a broad repertoire ranging from classical bioavailability and bioequivalence studies, drug-drug and drug-food interaction studies to SAD and MAD studies in the early phase, including evaluation of metabolites, metabolic ratios and dose linearity/proportionality assessments. We also bring our experience to bear on specific issues, even if they are more exotic, such as GI tract absorption studies, faecal/urinary excretion studies, or phase II pharmacodynamics studies based on pharmacokinetic principles.

Our pharmacokinetic and pharmacodynamic study evaluations are based on SOP-supported and validated processes in WinNonLin, embedded in a CFR 21 Part 11 driven IT environment and design. The classical NCA is performed using precisely pre-planned processes, all relevant evaluation details are agreed with our customers in advance via the PK part of the Statistical Analysis Plan. If desired, we of course also work with the evaluation guidelines of our customers.

For more complex modeling questions, we cooperate with internationally recognized experts who allow us to adequately map your problem with the optimal method.

We will find the right answers on your statistics questions.
Dr. Ralph-Steven Wedemeyer is at your disposal.