Biometrics

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

We analyze the databases and publications provided by you with the aim of

Hypothesis Generation
Review of the requirements for sample size estimation
Detection of associations of parameters and possible interfering factors
Data visualization

Study concept

We provide consulting services in the development of a study concept. This includes:

Elaboration and clear formulation of the research question
Selection of suitable endpoints and hypotheses as well as appropriate statistical methods to test them
Sample size estimation
If necessary, selection of an adaptive study design

Study protocoll / SAP

We assist you in the development or preparation of the following:

the chapters on data collection and statistics in the study protocol (hypotheses, definition of planned analyses, specification of primary and secondary variables, specification of interim analyses, specification of evaluation populations)
the Statistical Analysis Plan (SAP)

Support of the study conduct

We assist you in the conduct of the study. This includes among others:

Planning and execution of randomizations
Execution of interim analyses

Validation

Our systems and solutions basically comply with the standards of GAMP-5 and are compliant with CFR 21 Part 11. Covered by our quality management system (QMS), study-specific solutions are comprehensively supported during conception, continuously quality controlled during development and validated on a project-specific basis before final evaluation.

Performance of the statistical analysis

Using SAS and/or WinNonLin we develop for you:

Template-based evaluations for standard questions. This makes it possible to provide you with your study results quickly.
Customized evaluations for complex questions
Meaningful graphics for visualization of the results
You receive tables and figures in RTF format.

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.