Highly qualified and experienced statisticians with PhD- or MSc-level qualifications.
We provide extensive experience in the following areas of drug development:
- Pre-clinical statistics
- Phase I, including pharmacokinetic analysis
- Phase II to phase IV studies
- Mega-trials
- Health economics and quality of life data
- Regulatory submissions
- Post-marketing studies
- Meta-analysis of safety and/or efficacy data
- Integrated summary tabulations and input into European, US and CTD
regulatory submissions
We offer services in the following areas:
- Statistical consulting in drug development
- Study design
- Sample size estimation
- Randomization
- Statistical evaluation and assessment of preclinical and clinical studies
- Statistical programming, including design and set-up of analysis data sets as well as design and programming of tables and figures
- Interim analyses
- Meta-analysis and data mining
- Statistical aspects of health economics and pharmaco-epidemiology
We provide statistical input into:
- Drug development plans and clinical development plans
- Study protocols
- Statistical analysis plans
- Study reports
- Regulatory documentation and meetings with authorities
- Publications and conference presentations
- Marketing material
- ISS, ISE, CTD, investigator brochure, etc.
We have extensive expertise in analysis and reporting of pre-clinical and clinical studies using statistical software:
- SAS®
- StatXact®
- LogXact®
- WinNonLin®
- nQuery Advisor®
- Sigma Plot
- SPlus
- Rando® (proprietary randomization software)
- SASenv (proprietary Clintrial®-SAS®-interface to transfer
data on a routine day-to-day basis from Clintrial® to SAS®
for consistency of clinical trial database and statistical analysis
datasets)
- Oracle Clinical
- Extensive library of SAS® programs and macros
Our track record in biostatistics covers major therapeutic areas such as:
- Oncology
- Cardiology
- Metabolism and Diabetes
- Inflammation and Rheumatology
- Immunology
- Hematology
- Neurology and Psychiatry
- Dermatology
- Allergology
- Anti-Infectives
- Plasma Proteins
- Vaccines
- Pediatric medicine
- Diabetes
- Cardiovascular medicine
- Rheumatology
- CNS disorders
- Infectious diseases
- Dermatology
- Immunology
- Coagulation disorders
- Woundhealing
- Preclinical and non-clinical statistics
- Phase I - II a studies and lead optimization programs
- Dose-Response studies
- Design and conduct of phase III drug development programs
- Megatrials
