Clinical Trial Services

The Biostatistics Department at HCRI includes statisticians and statistical programmers, all with masters or doctoral degrees, who have extensive expertise in designing and analyzing clinical trial data for interventional cardiology devices as well as other therapeutic areas. In addition, the group often collaborates with world-renowned faculty statisticians from the Department of Statistics at Boston University, Harvard School of Public Health and other academic institutions in the application of the newest statistical methodology to the analysis of data from HCRI clinical trials.

The department provides comprehensive statistical services and has experience designing and analyzing data from single- and multi-center trials.  The statistical analysis for each trial is lead by a statistician who works closely with academic and other physicians with quantitative methods.  This ensures an unbiased, scientifically-based interpretation of study results.

The department staff also performs statistical analyses used in publications, such as New England Journal of Medicine and Circulation, presentations at scientific meetings and abstracts authored by industry thought leaders.

The department provides the following services:

• Study design
• Sample-size calculations
• Interim analysis plans and criteria for trial discontinuation or modification
• Randomization schemes
• Analysis plans, database specifications, and mock tables
• Programming and validation of analysis databases and statistical tables, figures, listings, and advanced statistical analysis
• Input to interim and final study reports
• Statistical analysis for submissions including NDA, BLA, PMA and 510(k)