Biostatistics & Data Management

VIMTA is committed to enhance data quality through best data management support systems and an integrated approach to prepare eCTD and CDISC implementation for smooth regulatory submission procedures. Our BSDM services and activities include:

  • Sample size estimation for PK and therapeutic end point studies
  • Generation of randomization schedules for varied study designs
  • Pharmacokinetic and statistical analysis of data for PK and In-VitroBE studies using SAS
  • Handling data for average bioequivalence, reference scaling approaches and other customized designs
  • Compilation of reports and compliance with ICH requirements
  • eCTD compilation and publishing using TRS toolbox 6.3 Pharma
  • Preparation of CDISC compliant data sets
  • Annotated CRFs
  • SDTM datasets with validation
  • ADaM datasets with validation
  • Reviewers guides for SDTM and ADaM
  • xmls for SDTM and ADaM