Our 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.

• Statistical Consulting
• Data Standardisation (CDISC) and Integration
• Adaptive and Bayesian Designs
• DSMBs and Risk-Benefit Analysis

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:

• Industry information such as 21 CFR Part 11
• GCP and ICH standards such as ICH E9, Statistical Principles for Clinical Trials
• SAS software programming skills
• Statistical methodology

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.

• 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.