Biostatistics

Biostatistics

Clinart has an extensive experience to develop a statistically rigorous and customized plan for each project. Working as your partner, Clinart’s expert biostatisticians work closely with clients to determine the ideal methods for collecting, analyzing and presenting data, all in compliance with regulatory guidelines. Our plans reflect all relevant agency approvals and FDA/ICH guidance documents, as well as an understanding of pertinent medical and clinical issues. Clinart’s execution of the data analysis plan produces report ready summary tables, data listings and figures for interpretation and inclusion in the study report or submission. Sound data analysis is achieved through a comprehensive understanding of biostatistics, FDA guidelines, study objectives, issues and data, along with tight quality control procedures. Our programmers can create custom presentations, tables, listings, figures, and reports optimized for your unique study designs. A thorough verification and senior review process substantiates the accuracy and completeness of all statistical analyses.

Clinart is current with the latest statistical techniques in the literature as well as those accepted by the FDA, EMEA and other regulatory agencies. We assured that team members stay current with industry standards, such as CDISC naming conventions required for submissions to the FDA. Our senior Biostatisticians bring expertise and insights in designing trials and developing complex statistical analysis plans. Our Biostatisticians posses the critical thinking to assist Sponsors throughout the filing process. Our statistical programmers are current with the latest programming techniques and features of the SAS system, among other statistical software packages. Additionally, they are experienced with CDISC data standards, electronic submission standards and Clinart’s standards, to deliver high quality, dependable analyses.

Biostatistical Services include:

  • Consultation on study design, sample-size estimation, and statistical analysis planning
  • Study randomization
  • Analysis programming
  • Interim/sequential analysis
  • Data integration – ISS/ISE
  • Integrated report preparation
  • Integrated summaries of safety and effectiveness
  • CDISC data compliance and conversion
  • Expert data analysis
  • Data monitoring committee
  • Data browse/Query (Integrated Review™)
  • Statistical Reports
  • Preparation of SAS® data for FDA
  • Agency Representation
Copyrights © 2009 - 2010 ClinArt. All Rights Reserved.