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Statistical Science & Programming

At R&G, we know how critical an expert team of statisticians can be to the clinical development program. From the protocol design to the analysis of the final data, the quality of statisticians’ work will impact the study from the beginning to the end. Over the years our statistical team has worked with clients worldwide in terms of the protocol design, statistical analyses and programming, and assessment of the requirements for regulatory submissions. As our clients’ partner, R&G’s expert statisticians will work together closely with you and provide the best available methods for the design and statistical analyses to ensure the success of the study, all in compliance with regulatory guidelines.

Our Statistical Science & Operation team consisted of expert statisticians, either from US FDA or numerous major global pharmaceutical companies, have extensive experience in both regulatory and industry, and will provide all kinds of statistical services to satisfy your specific needs.

Our Statistical Services Include:

  • Development strategy consultation
  • Clinical trial design including Master protocols, adaptive, enrichment, non-inferiority and Bayesian design
  • Protocol development
  • Randomization schedules and implementation
  • Statistical analysis plan (SAP) development
  • Statistical methodology and simulation
  • Tables, Listings and Graphs design and verification
  • Case Report Form (CRF) review
  • Statistical Analysis Report (SAR) writing
  • Clinical Study Report (CSR) review and consultation
  • DSMB/Interim analysis
  • Submission strategy consultation
  • E-submission package preparation
  • Health authority advisory meetings

In either the drug development or submission process, it is extremely important to have a statistical programming team with both the expertise and experience to have timely deliveries for all complicated analyses and reporting outputs. At R&G our programming team has extensive experience in a range of therapeutic areas and has been well recognized in the field for their high quality deliveries, always beyond expectations, all the time.

Our Statistical Programming Services Include:

  • Develop programming specification
  • Develop SAS programs for CDISC standard datasets (i.e. SDTM, ADaM)
  • Develop SAS programs for Tables, Listings and Graphs in support of CSR, ISS/ISE, medical review, data report and publications
  • Develop SAS programs independently to perform quality control
  • Generate Define.xml , SDRG and ADRG to support regulatory submission
  • Building SAS macros/system for clients
  • Provide SAS training and instruction

If you would like to learn more about R&G, please download our brochure or feel free to contact us directly.

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