Statistical Services

  • Strategic planning for clinical development
  • Study design (PCS)
    • Power and sample size estimation
    • Adaptive design
    • Bayesian design
    • Enrichment design
  • Protocol, CRF review, and SAP development, and mock tables. CSR
  • NDA/BLA/EMEA submission
  • PMA/510(k) submission for medical devices
  • ISE/ISS/eCTD
  • Exploratory analysis
    • Data mining, early prediction, meta-analysis
    • Signal detection and monitoring
    • Planning and designing for new studies
  • Publication support
  • IDMC support (Charter and TLG development)
  • PK/PD data analysis and modeling
  • Simulation and bootstrapping study
NJS Associates
1170 Route 22 Suite 209
Bridgewater, NJ 08807
Tel: 973-960-8688
contact@njstat.com
home  |  about us  |  services  |  products and solutions  |  
contact us  |  careers

Copyright © 2013 NJS Associates