BioStatistics
Orbis Clinical statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often consulted to perform special calculations and summarizations of information for non-study related issues for problem solving and process improvement.

Our SAS programmers perform statistical programming and data programming, as well as providing tables, figures and listings (TFLs) based on the analyses and format specified in the Statistical Analysis Plan.

Comprehensive Biostatistic Services:

  •  Input on sample sizes and analysis of endpoints
  • Detailed statistical analysis plans
  • TFL generation including required statistical analysis
  • Consultation on statistical topics

Clinical Data Management
Orbis Clinical provides dedicated clinical data management consultants who know the importance of accurate and timely data management for your clinical trials.

Service Offerings

Study Setup

  • CRF design and development
  • Database build and testing
  • Edit Checks preparation and testing

Study Conduct

  • Data Entry
  • Discrepancy Management
  • Data Coding (MedDRA,WHODDE)
  • SAE Reconciliation
  • Data Transfer

 Study Closeout

  • SAE Reconciliation
  • Quality Control
  • Database Lock
  • Electronic Archival
  • Database Transfer

Contact us today to learn more!