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Statistical Analysis

At R&G, we know how vital an expert team of statisticians can be to the clinical development process. From the foundation of your Protocol design to the analysis of your final data set, the accuracy and precision of your statisticians’ work will affect your study from start to end – often having the power to make or break a study. Over the years our statistical team has assisted clients from all over the world to conduct thorough assessments of the requirements to support regulatory submissions in China and ensure the design of a sound Protocol. Working as your partner, R&G’s expert statisticians can help you put your best foot forward by reviewing your study’s needs and determining the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines.

Led by an industry expert of +20 years, +9 years of which were spent working as a XXX in the US FDA, and through our robust training program, our processes have evolved to keep up with the rapidly changing regulatory landscape. Our Statistical Analysis team is made up of statisticians and statistical programmers who are well versed in industry regulations and standards (21 CFR Part 11, CDISC etc.) and who keep current with guidance updates and developments.

Our Statistical Services Include:

  • Assistance with study design and sample size determination
  • Development of statistical analysis plans (SAP)
  • Assistance with Protocol writing
  • Determination of statistical models
  • Randomization schedules and implementation
  • Programming of tables, listings and figures in accordance with SAP
  • Case Report Form (CRF) review
  • AdaM development in compliance with CDISC Standard
  • Statistical analysis and reporting
  • Clinical Study Report review and consultation
  • Interim analysis and exploratory analysis

Please contact us for additional information on how our Statistical Analysis team can help improve the quality of your clinical studies, control costs and reduce your time to market.

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