Data science and biometrics

The Data Sciences team at Quotient Clinical comprises over 50 staff members. Our team provides an expert service for early phase clinical studies, both for healthy volunteer and patient, and includes the following functions:

Data management and programming

  • Study eCRF set-up and maintenance
  • DM Plan, data cleaning, coding, query issue and database lock

Statistics and statistical programming

  • Protocol input, sample size calculation & randomisation,
  • Statistical analysis plan and formal statistical analysis/interpretation
  • Program/QC study listings, tables and figures using SAS
  • Program/QC CDISC datasets (SDTM and ADaM) using SAS

Pharmacokinetic modelling and simulation

  • PK modelling using WinNonlin
  • Modelling and simulation using GastroPlus
  • Scintigraphic analysis

Medical writing

  • Protocol writing
  • Clinical study report according to FDA guidance for industry and related submissions using eCTD specification

 

data management, statistics, programming, medical writing, PK,