Statistical Services

• Strategic planning for clinical development
• Study Design(PCS)
• Power and Sample Size Estimation
• Adaptive Design
• Protocol ,CRF review, & SAP Development, and mock Tables. CSR
• NDA/BLA/EMEA Submission
• ISE/ISS/eCTD
• Exploratory Analysis
• Data Mining, Meta Analysis
• Signal detection
• Planning and designing for new studies
• Publication Support
• IDMC Support (Charter and TLG Development)
• PK/PD data analysis and modeling
• Simulation and Bootstrapping Study