Study design, ethics, reporting
In addition to our main services we offer a wide range of additional services to our customers ranging from study design and ethical approval to data management, statistical analysis and reporting.
We have implemented screening methods for 92 cytokines and 75 eicosanoids and we can perform highly sensitive quantification of selected PD markers.
We develop, optimize, qualify, validate and automate all PK/PD-bioanalysis for high-throughput analysis. All PK/PD-bioanalysis is performed with highly sensitive state-of-the-art mass spectrometry analytics according to GLP guidelines.
Data management and statistics
We develop Source Data Forms and electronic Case Report Forms using OpenClinica(R) according to your database requirements.
We perform comprehensive data management including user training, data cleaning, plausibility checks, outlier handling, query management, data base release meetings, data base lock and archiving.
We develop the Statistical Analysis Plan (including sample size calculation) and perform and validate the clinical statistics.