Biostatistics – Programming


Clearly defining study objectives and validating study design is essential to project success.  The data sets, collection process and interpretation and reporting mechanisms need to be optimized to ensure the statistical accuracy of your trial, whether for traditional designs or emerging strategies.

The statistical team at Clinlogix provides customers with solid statistical work and advice. The team works closely with sponsors to develop and execute statistical analysis plans that match the specific goals and needs of clinical trials.

To ensure an efficient workflow, our statisticians are part of the project and data management teams and provide input on the eCRF design for best data collection practice, and for any data handling issues that need to be resolved for analysis.

Our experience translates to expertise in statistical consulting, design, and operation of traditional and adaptive design trials for all phases from initial dose titration through post-approval services including:

  • Protocol design, analysis and endpoint strategies
  • Development and implementation of statistical methodologies
  • Case report form review
  • Statistical Analysis Plan (SAP)
  • Programming
  • Data analysis and reporting
  • Medical writing services
  • Clinical development planning
  • Randomization schedule creation
  • Support for medical writers and clinical scientists to ensure appropriate interpretation
  • Support for manuscripts and abstracts

Based on a well-developed plan, the statistical analysis implementation provides Clients with timely, high-quality deliverables. We ensure complete, concise reporting in CDISC:

  • ICH compliant analysis strategies
  • Production of audit-ready tables, listings and figures
  • Development of comprehensive methods reports describing planned and exploratory analyses