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Statistical Analysis

Statistical Analysis

CBS has been involved in the analysis of data from all stages of clinical development with a variety of designs and statistical hypotheses including interim, meta-analyses using adaptive, sequential, and sample size adjustment designs.

The CBS Biostatistics team offers a range of services with quality that is derived from decades of experience and industry associations. Our experts covering:

  • All Phases of clinical trials and publications
  • All types of submission (IND, NDA, sNDA, PMA, 510k etc.) for all of the major regulatory agencies (FDA, EMEA, PMDA, EFSA)
  • A wide range of therapeutic areas including Oncology, Neuroscience, Cardiovascular, Respiratory, Infectious Disease, Immunology/Vaccines, Analgesics, Ophthalmology
  • Diverse statistical methodologies including Bayesian, multiple imputations, simulations, mixed effects, survival analyses, and multiple comparisons
  • Diverse experience in trial designs including parallel, crossover, adaptive, observational, non-inferiority, and group sequential

The CBS Biometrics staff has also been involved in Independent Data Monitoring Committees to assist in the decision-making process or to offer statistical support independent from the sponsor.

The Statistical Services offered at CBS Biometrics are:

  • Protocol development
  • Clinical Study design and Sample sizes determination
  • Creation Statistical Analysis Plans (SAP) including mock shell development
  • Statistical oversight of clinical dataset development (e.g. SDTM and ADaM)
  • Producing/Validating Randomization schedules
  • TFL Design &Programming
  • Perform Exploratory analyses
  • Publication support.

Our statistical programming services include:

  • Observed Datasets development (e.g. SDTM)
  • Analysis Data Sets development (e.g. ADaM)
  • Legacy studies conversions to CDISC standards
  • Data integration (e.g. ISS and ISE)
  • Tables, Figures, and Listings (TFLs) development
  • Submission Ready Documents (DEFINE.XML) generation
  • Analysis to Support Regulatory Submissions (CDISC standards are preferred)
  • Publications
  • Exploratory Analysis
  • Data Mining
  • Data Visualizations