ICON provides biostatistic services for clinical development plans, study design, statistical analyses, and regulatory support.
ICON's team of experienced statisticians and programmers produces comprehensive, high-quality, timely analysis and reporting of study results across a broad range of therapeutic areas. We have extensive knowledge of experimental design, statistical methodology, and global regulatory requirements.
Main Service Offerings
Expert Statistical Scientists
ICON’s global biostatistics team has an average of 12 years’ experience and 40% have a Ph.D. All of our statisticians and statistical programmers receive ongoing, intensive training that incorporates:
Team members are also current with industry standards and market trends, such as Clinical Data Interchange Standards Consortium (CDISC) models. As per client agreements, our data is often formatted to CDISC standards for consistent reporting to regulatory authorities.
The standards established by the Clinical Data Interchange Standards Consortium (CDISC) are becoming the established way to collect, analyse and submit clinical trial data with agencies around the world adopting CDISC as their preferred format for submission. Therefore, many companies are facing the challenge of working with legacy databases.
Benefits of partnering with ICON on CDISC:
In the past 5 years, our biostatisticians and programmers have supported over 500 Phase I-IV clinical trials, involving 107,000 patients across all major therapeutic areas. To date, ICON’s global team of biostatisticians have supported 40 studies involving Drug Safety Monitoring Boards (DSMBs). Our biostatisticians have generated over 124 CDISC compliant (SDTM) datasets.
ICON’s Biostatistics Group has been involved in over 30 adaptive design studies, including sample size re-estimation, changing hypotheses, and combining phase II/III.