BIOMETRICS
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
