Study Design

Protocol development and review
Sample size
Randomization

Statistical Analysis

Statistical analysis plans
Phase I – Phase IV Clinical Trials
Adaptive and Sequential
Bayesian
Subgroups and outliers using proprietary software and novel statistical method
Pre-study epidemiology analysis to determine the cost burden of a particular indication
Economic, behavioral and humanistic endpoint analysis from ongoing studies
Post-marketing analysis for comparative studies and claims
Models to support submission for reimbursement
Design and analyze quality-of-life (QOL), including treatment group comparisons
Prepare findings for regulatory submission, journal publication and coverage
Identify public, private and government audiences for outcomes data


	Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Bioanalytical Method Validation

Biostatistics Brochure

Pharm-Olam's biostatisticians are available to help with your statistical needs from protocol design to dissemination of results across all therapeutic areas.

Argentina (Buenos Aires), Belarus (Minsk), Belgium (Brussels), Brazil (São Paulo), Bulgaria (Sofia), Canada (Toronto), Croatia (Zagreb), Czech Rep. (Prague), Georgia (Tbilisi), Germany (Munich), Hungary (Budapest), India (Bangalore), Italy (Milan), Kazakhstan (Almaty), Mexico (Mexico City), Poland (Warsaw), Romania (Bucharest), Russia (Moscow, St. Petersburg, Novosibirsk), Serbia (Belgrade), Spain (Madrid), South Africa (Johannesburg), Ukraine (Kiev), United Kingdom (London), United States (Houston, Princeton, Research Triangle Park)