Resource optimization: Uncharted territory in vendor oversight

In a recent Comprehend webinar, Laurie Halloran presented some stimulating ideas on how to address an underserved issue in optimizing resources between Sponsors and CROs. It has come up repeatedly that a lot of the stress felt between these two groups comes from misaligned goals, roles, and expectations.
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Behind closed doors at CORE 2017

The happenings at Halloran’s Clinical Operations Retreat for Executives (better known as CORE) have long been kept under wraps. This year marked the 11th retreat, and we wanted to give everyone a peek inside.
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Three Orphan Drug Program problems and how the FDA plans to fix them

When the FDA bestows an “orphan” designation, it validates a product’s potential benefit. However, sponsors can pursue and receive an orphan designation for a pediatric population which waives Pediatric Research Equity Act (PREA) requirements and exempts the product from clinical studies in a pediatric population.
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