PROVIDING EXPERT DESIGN AND ANALYSIS FOR YOUR CLINICAL TRIALS
OUR SERVICES
In support of clinical trials, BCI provides a full range of statistical and programming services to the pharmaceutical, biotechnology, and medical device industries, including all of the following:
STRATEGIC STATISTICAL CONSULTING STUDY DESIGN • Classical and adaptive designs • Sample size and power calculations • Writing statistical sections of protocol • CRF review • Randomization • Statistical analysis plan (SAP) development
STATISTICAL ANALYSES AND REPORTING • Interim analyses • Final analyses • Production of tables, listings and graphs • Writing statistical sections of Clinical Study Report • Integrated Summaries of Efficacy and Safety
DATA MONITORING COMMITTEES • Participation as statistician on DMC • Statistical support for DMC
STATISTICAL REPRESENTATION WITH REGULATORY AUTHORITIES • FDA • European and Japanese regulatory authorities
STATISTICAL SUPPORT FOR REGULATORY SUBMISSIONS • IND, NDA, and BLA • IDE, PMA, and 510(k)
