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ONE SIZE DOES NOT FIT ALL – A DIAGNOSTIC COMPANY PERSPECTIVE ON CLINICAL OUTSOURCING
For many CROs, diagnostic companies represent an untapped market. When a clinical operations team seeks an outsourcing partner, they need a realistic proposal, fast. Diagnostic companies often find, however, that CROs don’t speak their language. Knowledge gaps about...
read moreA DIAGNOSTIC PRODUCT WENT TO MARKET, STEP 1: DEFENDING THE IDEA
A new diagnostic test starts with a hypothesis: we’ve identified an underserved clinical problem, and our solution presents a market opportunity. Success depends on a systematic, step-wise approach from hypothesis to market. At 30,000 feet, we can describe...
read moreCLINICAL PROTOCOL DESIGN FOR DIAGNOSTICS DEVELOPMENT
To develop a diagnostic test, we need samples. Archived cohorts can be used if they are available. But when biobanks aren’t enough – because they are difficult to acquire, lack important clinical annotation or collection and handling characteristics, or...
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