biostatistics and data management





  • Paper and EDC trials
  • CRF development
  • Data Management Plan
  • Database design, setup and data warehousing of clinical trial project
  • Data migration, mapping and imports
  • Programming of edit checks and data cleaning
  • MEDDRA and WHO data coding
  • IWRS and customized randomization
  • Mapping to CDISC standards compliance
  • Compliance with FDA’s (21) CFR Part 11
  • Statistical analysis plan
  • Sample size and power calculation
  • Randomization
  • Interim reports
  • Statistical methods, shells, patient profiles, data tables, listing and figures
  • SAS® programming
  • Integrated clinical study report
  • Datasets and analysis database in various formats
  • CDISC standards compliance
  • Regulatory Submission Packages