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Glossary



Biostatistics & Data Management

WorldCare Clinical’s specialized expertise in biostatistics and data management services is built on a scientific approach to imaging. Led by a Director of Biostatistics and Data Management with extensive experience in analysis and validation of clinical trial data, WCC provides sponsors with the most accurate and reproducible datasets available.

 

Our intensive attention to operational metrics and clinical statistics in particular maximizes the value of our services by advancing and improving the precision of imaging across all modalities. As a member of the Metrics Champion Consortium’s Imaging Metrics Working Group, we now offer v1.0 of the MCC’s Imaging Performance Metrics (including exploratory reader variability metrics) to all sponsors’ imaging trials through our WorldPro® technology platform. And our measured control of reader variability spans the entire duration of the study, from advanced tools to measure reader performance and improve assessment precision to image quality control and streamlined reader training and testing.

 

For each trial, a robust training and testing plan is developed that includes:

 

  • Intra- and inter- reader reliability using Cohen’s and/or weighted kappa and concordance correlation coefficient, ordered categorical data, and advanced precision tools
  • Selective performance testing allow ongoing inter-reader and intra-reader assessment of performance at any time, with a focus on difficult-to-interpret cases

 

We also maintain regular communication with the entire reader team by providing trial-specific newsletters with data on individual and team performance, study assessment criteria and evaluation discussion, and specific highlights of challenging cases.

 

Data Management

  • Imaging eCRF creation and data management
  • Data management guidelines, data transfer file specifications including comprehensive validation of WorldPro™-produced deliverable
  • Data export in sponsor-specified format (e.g. SAS Transport, CSV, xml, etc.)
  • Data analysis and SAS programming
  • Imaging data audit submission and management

 

Biostatistics

  • Statistical analysis planning
  • Comprehensive image reader training prior to assessment period
  • Reader variability testing
  • Consulting services regarding various adjudication paradigms