Services

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.
  • Data Management
    • eCRF design & system configuration
    • Data management plan
    • Database design 
    • Medical coding (MedDRA, WHODrug)
    • Electronic Data Transfer (EDT) to Medidata Rave® or other systems with open interface standards
    • CDISC compliant format (Study Data Tabulation Model - SDTM)
  • Biostatistics & Programming
    • Sample size calculations
    • Treatment randomization 
    • Statistical analysis plan development
    • Interim analyses
    • Statistical consulting & Trial designs
    • Summary tables, listings and figures and Listings (TLFs)
    • Integrated Safety Summary (ISS) 
    • Integrated Summary of Efficacy (ISE)
    • ADaMs (Analysis Data Model) CDISC compliant format
  • Pharmacokinectics & Pharmacodynamics
    • Noncompartmental PK & PD analysis
    • Toxicokinetic analysis & Bioanalytical data review
    • PK reports
    • Population PK analysis
  • Medical Writing
    • Protocol preparation
    • Fully integrated clinical study reports
    • Patient narratives
    • Standard Operating Procedures (SOPs)