Product/Service

Biostatistics

Source: ICON

Translational Medicine

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

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

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:

  • 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.

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:

  • ICON has over 200 staff in Biostatistics & Programming located across 3 continents with CDISC expertise
  • Our in-depth understanding of CDISC provides us a unique perspective which enables us to assist our sponsors in compiling CDISC compliant deliverables
  • Greater efficiencies and cost-savings for the successful completion of submission ready data
  • Improvement in review and analysis of clinical trials data through integrated tools and processes
  • Metadata driven approach to data mapping, successfully automating validation, annotation of the CRF, and generation of the define.xml
  • Provision of tailored models supported by CDISC experts to partner you through data requirements with respect to CDISC data production
  • Parallel and peer review driven processes to ensure quality and consistency throughout the submission process

Comprehensive Experience
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.