We are professional biostatisticians who are skilled and highly efficient in applying strong quantitative skills, excellent research expertise and strong consulting expertise to biomedical research studies. We have spent careers conducting sophisticated statistical analyses and delivering expert advice and support for various biomedical studies. Our consultants regard themselves as statistical scientists as they always immerse themselves in the therapies and norms of the disease area in hand. Drawing on years of experience from academic and industrial research, we provide expert advice and support for various statistical aspects of biomedical studies including clinical trials, genetics studies and epidemiological /observational studies, from the study design phase to the reporting phase. We also provide training in various statistical methodologies and utility of various statistical analysis packages.
Advice: We provide advice on all statistical aspects of clinical studies from the design stage to reporting and publications.
- Study design
- Protocol and synopsis development
- Sample size calculations
- Randomization Plans
- Electronic clinical database development support
- Data Monitoring Committee (DMC) support
- Support for regulatory submission
Analysis and programming: We work with project teams providing expert statistical support and developing various statistical documents required for successful conduct and completion of clinical study. We develop programs required to generate results tables and perform in-depth reviews of statistical outputs.
- Statistical analysis plan development
- Tables, Listings and Figures (TLFs) specification creation
- SDTM and ADaM creation and validation
- TLFs Programming (in SAS) and review
- Pre-clinical and clinical trials data review and analysis
- Pharmacogenetics & genomics data analysis
- Epidemiological /observational data analysis
- Scientific programming using SAS, S-Plus/R, Stata, C/C++.
Reporting: We provide statistical support for the creation of various reports required for communications of study results.
- Clinical study report development support
- Statistical report creation
- Manuscript development and review
- Patients profiles
Training: We give training on statistical methodologies and use of statistical packages for data analyses.
- Training in statistical methodologies
- Training in statistical packages (SPSS, SAS, STATA, Splus/R)
Founder and Managing Director