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RAS Capabilities — Biostatistics and Data Management

RAS offers broad biostatistical expertise to support optimal trial design decisions, build the right dataset to achieve your target product profile, and perform critical analyses and reporting for your submission.

Biostatistics

Dataset Construction

Biostatistics

Statistical Plan Development:

  • Protocol and CRF development
  • Statistical analysis plans and SAS® programming to increase your probability of success and optimize design of subsequent trials
  • Development of randomization schedules (adapting randomization procedures to account for matching schemes, stratification, sequential analysis)

Statistical Analysis and Listings:

  • ANOVA (BE, dose proportionality, power and sample size calculations, statistical outlier tests)
  • Generalized mixed-effects models, multiple linear regression models, non-parametric tests, pairplot and cluster analysis
  • ROC analysis to identify covariate(s) that maximize probability of response
  • Survival analysis (Kaplan-Meier, Cox proportional hazard modeling, time-dependent covariates, competing risks)
  • Prediction of dichotomous outcome (conditional [matched] and unconditional [unmached] logistic regression)
  • Interim data analyses (extrapolation of results to optimize next study or phase)
  • Post-approval statistical evaluations, including sub-group analyses

Statistical Report Writing:

  • Integrated safety (ISS) and efficacy (ISE) summaries
  • Interpretation and preparation of safety tables and reports using SAS

Regulatory Support:

  • Biostatistical support at regulatory meetings (including addressing clarifications to global regulatory agencies on applicability of study results)
  • Support for advisory panel and data monitoring committee meetings
  • CDISC consulting to comply with clinical data system and e-submission requirements
  • Publication and abstract preparation

Dataset Construction

RAS scientists have expertise in designing and constructing datasets to support population PK/PD modeling strategies:

  • Database design and integration (pooling study data from multiple sources, including complex PK/PD data; statistical methods to account for inter-study differences to increase power and confidence in design of next trial)
  • NONMEM® datasets are constructed using
    S-PLUS®
  • S-PLUS scripts can be provided with support services for flexible time periods according to client needs

Modeling and Simulation Analysis Plan (MSAP):

  • The goal of the MSAP is to reduce the time required for analysis by providing a priori sets of rules on model build-up and how missing data will be handled

PK Study Archiving and Real Time Data Assembly

  • Services to build and maintain the required database of data and reports for submission, as PK studies are completed. Building the dataset during the study ("real-time data assembly") minimizes delays in analysis, and leads to earlier decisions.
  • Pharsight Knowledgebase Server™ (PKS™) functions as the compliant data repository for PK study archiving.