Tagged: diagnostic

Tips for Success in Large Subject-Based IVD Studies

In development of IVDs, the transition to large subject-based studies is a major milestone in progress toward marketing approval. The test product has proven itself in reproducibility and validation studies, often involving banked samples. The developer can see years of effort at last culminating in revenue generation.  Only one step remains – a large subject-based… Read more »

Faster to Market, Faster to Fail

The team at Health Decisions enjoys nothing more than helping a sponsor bring a successful product to market months or years ahead of schedule. Through a combination of adaptive design and adaptive operations, we have succeeded in accelerating market entry for many products, sometimes by more than two years, as in the case of one… Read more »