Paving the way for effective reporting and successful regulatory submissions

Our data management team collaborate closely with statistics, to ensure seamless, timely delivery of clean data, allowing our biostatisticians a clear runway for analysis and reporting.

Statistical analysis services include:

  • Study Design
  • Independent protocol review
  • Sample Size Calculation
  • SAP development
  • Programme listings, figures, tables
  • Final analysis & Statistical report
  • Independent Statistical Analysis Review
  • Regulatory Submission Support

Successful Regulatory Submissions

Statistical input during the development of the protocol ensures you get the data you need out of your study. Where required, our biostatisticians also support the preparation of regulatory submissions through structured reporting, tailored to satisfy your specific MAA requirements.