Services

What we can do for you.

Statistical Strategies & Representations

  • Statistical Strategies in Clinical Development
  • Statistical Rep. in Regulatory Interactions
  • Statistical Strategies in Portfolio Management
  • Business Development Strategy Optimization
  • Statistical Representation at DMC, Advisory Board

Statistical Services

  • Bayesian/Other Innovative Clinical Trial Design
  • Statistical Analysis Plan (SAP)
  • Statistical Project Management
  • Clinical Study Report
  • Typical Trial Design
  • Statistical Support during Protocol Development
  • Interim Analysis / IBs / ARs / DSURs
  • Independent Data Review Committee
  • Ongoing Data Monitoring Plan/Analysis
  • Publications/Conferences

Data Management

  • CRF Design & Certified Database Build
  • Medical Coding (MedDRA & WHO)
  • Data Management Plans (DMP)
  • Lab Administration
  • Data Reconciliation (SAEs, External Data)
  • CRF Completion Guide (CCG)
  • Data Query Management
  • Database Lock
  • Ongoing Data Quality Monitoring and Cleaning

SAS Programming

  • CDISC Compliance SDTM Creations
  • Analysis Dataset Creations — ADaM
  • TFLs Creations
  • Ongoing Programmatic Data Quality Check
  • Interim/Ongoing Data Analyses
  • Ad/Post Hoc/Publication/Conferences