BIOSTATISTICS

We strive to deliver quality and implement the best approach to ensure correct analysis without an over complex process. Our approach is tailored to our clients’ needs. That is the basis for long-term partnerships and enables our biostatisticians to transfer their knowledge on to our clients.

Our Biostatistics Services include:
  • Protocol Input – our input includes clinical study design, sample size calculations and consultancy.
  • Randomization/Unblinding.
  • Statistical Analysis Plan (SAP) and Mock Shells.
  • Output Production – using our standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
  • Production of Statistical Report/Clinical Study Report.
  • Interim Analysis/Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support and advice for Interim Analyses and DSMBs.
  • Non/Pre-Clinical Studies – we provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.
  • ISS/ISE - we provide support for the integration of safety and efficacy data prior to regulatory approval.