PK/PD Studies
One-Stop-Shop
From developing a research protocol to reporting your results, we can provide you with the following services in our “one-stop shop”!
- Developing research protocols
- Preparing and submitting documents for ethical review
- Conducting preclinical and clinical studies
- Implementing and validating bioanalytical studies
- Developing quality-assurance/quality control procedures and data management systems
- Analyzing statistical data
- Reporting results
Services
Study Design, Data Management, Statistics
Before your study begins
- Support while developing your research protocol (statistical analysis plan, meta-analyses, sample size and power calculations)
- Design of case report forms (CRFs) and implementation in an electronic form (eCRFs)
- Validation of eCRFs
- Development of data management plans
During the study
- Collection and management of study-specific data using the eCRF
- Validated import of external data
- Management of queries within the study context
- Care and maintenance of large, existing data sets
- Interim analyses
At the end of a study
- Data cleaning and data sharing
- Data analyses and statistical modeling
- Processing and interpretation of results
- Assistance while writing publications
Bioanalysis
We carry out bioanalyses and pharmaceutical analyses in our GLP-certified laboratory. We use highly sensitive methods that allow us to process sample volumes in the microliter range and analyze low concentrations with the latest bioanalytical methods.
We develop, optimize, qualify, validate, and automate innovative bioanalytical methods for high-throughput analyses.
We have many years of experience working with various biological matrices (serum, plasma, interstitial fluid, tissue, cell cultures).