Stand alone statistical Analysis and Reporting services

  • Review of Statistical Analysis Plan (SAP) and Mock-up Shells
  • Data pooling and integrated analysis (ISS, ISE)
  • Support Clinical Study Report (CSR), Safety Monitoring, Interim and Exploratory Analysis, Patient Profiles/Safety Narrative
  • PK/PD Analysis
  • Analysis for BA/BE Studies, Meta Analysis
  • Independent data analysis center to perform interim blinded analysis, support for DSMB and IDMC
  • SAS Programming – SDTM/ADaM Datasets and Tables, Listings, Figures generation
  • Conversion of legacy data to CDISC-SDTM, CDISC-ADaM standards
  • Development, verification and validation of standard macros
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