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ONE SIZE DOES NOT FIT ALL – A DIAGNOSTIC COMPANY PERSPECTIVE ON CLINICAL OUTSOURCING

ONE SIZE DOES NOT FIT ALL – A DIAGNOSTIC COMPANY PERSPECTIVE ON CLINICAL OUTSOURCING

by Lyssa Friedman | Feb 28, 2018 | Uncategorized

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...
A DIAGNOSTIC PRODUCT WENT TO MARKET, STEP 1: DEFENDING THE IDEA

A DIAGNOSTIC PRODUCT WENT TO MARKET, STEP 1: DEFENDING THE IDEA

by Lyssa Friedman | May 5, 2015 | Uncategorized

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 these...
CLINICAL PROTOCOL DESIGN FOR DIAGNOSTICS DEVELOPMENT

CLINICAL PROTOCOL DESIGN FOR DIAGNOSTICS DEVELOPMENT

by Lyssa Friedman | Apr 5, 2015 | Uncategorized

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 because there...
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