Who We Are
The RABI Solutions Biostatistics team offers a range of services with quality that is derived from decades of experience and industry associations. Our experts have an experience covering:
All Phases of clinical trials and publications
All types of submission (IND, NDA, sNDA, PMA, 510k etc.) for all of the major regulatory agencies (FDA, EMEA, PMDA)
A wide range of therapeutic areas including Oncology, Neuroscience, Cardiovascular, Respiratory, Infectious Disease, Immunology/Vaccines, Analgesics, Ophthalmology
Diverse statistical methodologies including Bayesian, multiple imputations, simulations, mixed effects, survival analyses, and multiple comparisons
Diverse experience in trial designs including parallel, crossover, adaptive, observational, non-inferiority, and group sequential
What We Provide
Our broad range of services include:
- Protocol development
- Clinical study design and sample size determination
- Producing/validating randomization schedules
- Creation of Statistical Analysis Plans (SAP) including mock-shell development
- Statistical oversight of clinical dataset development (e.g. SDTM and ADaM)
- Producing/validating randomization schedules
- Producing/validating randomization schedules
- Statistical oversite of tables, figures, and listing development
- Perform exploratory analyses
- Function as the blinded or unblinded DMC statistician
- Publication support