Diagnostics Trials

Health Decisions offers unrivaled capabilities in IVD and other diagnostics trials

Health Decisions has successfully conducted a variety of large subject-based trials that supported successful Premarket Approval and 510(k) clearance submissions. We provide IVD developers with unmatched capabilities for streamlining clinical trials and reducing timelines and risk in diagnostics studies. Our capabilities for large subject-based IVD studies are the best in the industry. Our experience includes conducting a successful 12,776-subject study of a diagnostic for colorectal cancer and a successful 4,006-subject trial of a molecular HPV diagnostic.

Health Decisions is the CRO of choice when transitioning to FDA-required subject-based studies. Capabilities include end-to-end sample tracking and tracking enrollment by subtypes of results. Health Decisions has a track record of obtaining early regulatory agreement on control groups (concurrent or historical), objective endpoints (eliminating bias), quantitative cut points on positive and negative results, and handling of indeterminate results in the statistical analysis.

Diagnostics Development Services

  • Project Management
  • Site feasibility and selection
  • Site management
  • Site monitoring, including risk-based monitoring
  • Patient recruitment and retention
  • Data management
  • Statistical programming
  • Statistical analysis and reporting
  • Tracking enrollment by subtypes
  • End-to-end sample tracking
  • Collecting and monitoring pathology data
  • Regulatory oversight and compliance
  • Medical writing
  • Quality assurance