SPECIALIZED SERVICES

PROMETRIKA delivers highly streamlined and tailored services for very specific needs at any stage in a clinical research program, including:

  • Stand-alone database build and User Acceptance Testing (UAT)
  • Phase 1 data management, analysis and reporting, including PK/PD analyses
  • CDISC SDTM conversion programming to generate submission-ready datasets accompanied by the required documentation
  • Comprehensive support of Independent Data Monitoring Committees (IDMC), independent adjudication committees, clinical event committees
  • Independent validation of SAS® programs
  • Adaptive clinical trial design
  • Stability analyses for drug expiration dating
  • Statistical validation of centralized randomization via IVRS
  • Randomization call center services
  • Phase 4 support, including exploratory analyses and editorial services related to abstracts, posters, manuscripts, and scientific meeting presentations