Biostatistics & Data Management

When it comes to reader review and data management, precision and control are of the utmost importance. That’s why WorldCare Clinical’s scientific approach to imaging provides sponsors with the most accurate and reproducible datasets available.

WCC’s focus on operational metrics and clinical statistics continues to advance and improve the accuracy of medical imaging. To ensure data validity throughout the trial process, WCC follows a sophisticated statistical program that includes the creation and validation of critical listings to support FDA audits, SAP consulting, statistical methodology development for reader training and testing, and sample size estimations for reader variability testing. This means that all sponsors can be assured of a streamlined FDA review process that can be verified against WCC’s independent data.

From Start to Finish

From advanced tools that improve assessment precision to an image quality control process that streamlines reader training and testing, WCC’s measured control of reader variability and unparalleled commitment to data accuracy spans the entire duration of the study.

For each trial, WCC takes an adaptive approach to training and testing by developing a plan that includes:

• Quantitative analysis of inter-reader variability data using kappa and/or concordance correlation statistics
• Selective performance testing that allows ongoing inter-reader assessments of performance at any time, with a focus on difficult-to-interpret cases. We review the trial design and statistical analysis plan and determine what reader variability testing is required. This is all done in a prospective, cost-effective manner, starting with inter-reader variability testing and then intra-reader testing if needed or if required by regulatory agencies.

We also maintain regular communication with the entire reader team by providing trial-specific newsletters that include data on individual and team performance, study assessment criteria, evaluation discussions, 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