From the start of each trial through completion, the biostatisticians and programmers at Integrium have a clear understanding of the overall goals, so they can appropriately collaborate with clients, offer insightful analysis and customize data programs to fit clients’ needs. Our highly experienced staff are involved with and accessible to both internal and external teams at all points during the study. Their contributions are critical to successfully determining study feasibility, developing protocols, and writing accurate reports and materials for publication. With quality assurance built into all of our procedures, the Biostatistics and Statistical Programming team is able to deliver a full line of services efficiently and accurately. These services include:

• Development of statistical analysis plans (SAP)
• Randomization schemes
• Sample size and power analyses
• Statistical programming to generate top-line results as data summaries and/or data listings
• Statistical analysis for a variety of study designs
• Exploratory analyses
• Analysis of datasets in SAS®
• Stand-alone statistical reports
• Clinical study and statistical reports, separated or integrated
• Regulatory submission support, including integrated summaries of safety and efficacy
• Analysis database generation
• Meta-analysis projects
• Publication support

One of the most unique aspects of Integrium's biostatistics team is their rapport with our medical teams. They are well versed in the cardiovascular and metabolic disease literature, so they’re able to effectively collaborate to develop protocols and reports that are meaningful to the medical community at-large. Our expertise in these therapeutic areas also means that we can turnaround these protocols and reports quickly. Additionally, we’re also able to save time when delivering documents for approval or publication because our biostatisticians proactively plan for what will be needed with our medical writers.