Statistics

The statisticians of Dr. Manfred Koehler GmbH render qualified assistance in design and performance of your studies. They perform analyses for pre-clinical dose-finding safety and efficacy studies, large sample-size registration trials and post-marketing surveillance studies.

The computed professional experience of our five most senior statisticians exceeds more than 100 work years.

Our biostatistical services include:

• Contribution to study design
• Power analysis and sample size calculation
• Randomization – including phone based (IVRS) and web based (IWRS) randomization
• Statistical analysis plans
• Database integration
• Statistical programming
• Customized tables, listings and figures
• Periodic data monitoring and safety reviews (DSMB)
• Analysis of pre-clinical and Phase I-IV clinical trials of various designs
• Statistical reports
• Submission datasets based on current CDISC guidelines
• Comprehensive database and SAS program documentation