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Statistical Science & Operations

At R&G, we know how vital an expert team of statisticians can be to the entire drug development process – often having the power to make or break a study. From the foundation of your development strategy, clinical trial design and statistical analysis plan, to your study results delivery and regulatory submission, a good drug development strategy and robust trial design can highly increase your chance of success, lower the cost and shorten the overall time scale for your drug to reach the market.

Over the years our statistical team has worked side by side with clients from all over the world to develop drugs and other healthcare products, in various therapeutic areas, from strategy/concept development to tactical execution. During any collaboration at R&G, we do not see ourselves as a CRO, but rather an extension of your team. Working together as your partner, our expert statisticians can help you put your best foot forward and avoid costly mistakes further down the line.

Led by Dr. Gang CHEN, an industry expert, former Statistical Review Team Leader for Oncology Drug Review Division in the US FDA and Head of Quantitative Science, China, J&J, our Statistical Science & Operation team is made up of statisticians with rich industry experience from numerous major global pharmaceutical companies. We can offer you all aspects of statistical services to fit your specific drug development needs with rigorous scientific rational, optimized operation processes and global quality standards.

Our Statistical Services Include:

  • Development strategy consultation
  • Clinical trial design and sample size determination
  • Protocol development
  • Randomization schedules and implementation
  • Statistical analysis plan (SAP) development
  • Statistical methodology and simulation
  • Tables, listings and figures design and verification
  • Case Report Form (CRF) review
  • Statistical Analysis Report (SAR) writing
  • Clinical Study Report (CSR) review and consultation
  • DSMB/Interim analysis
  • Exploratory analysis
  • Submission strategy consultation
  • E-submission package preparation
  • Health authority advisory meetings

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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