Biostatistics and Statistical Programming
Our biostatistics team includes PhD statisticians with extensive experience in the pharmaceutical industry and academia, including interaction with FDA statisticians and other reviewers.
Our statistical programming group has strict quality control procedures and is dedicated to producing high quality work even under the most stringent timelines.
The services we provide cover the entire spectrum of pharmaceutical statistics from pre-clinical to Phase IV clinical trials. PROMETRIKA offers the following biostatistics and programming services:- Clinical Development Planning
- Study Design and Protocol Development
- Writing Statistical Sections of Protocols
- Sample Size Estimation
- Randomization Plans
- Statistical Analysis Plans
- SAS® Programming
- Interim Analyses
- Writing Study Reports
- Meta Analyses
- Development of ISS, ISE and Statistical Sections of NDAs
- Safety Monitoring Boards
- Analysis of Stability Data for Drug Expiration Dating
- Design and Analysis of Cost-Effectiveness and Quality-of-Life Studies
- Epidemiological Research