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Saving time and money - Qualifying clinical plan

Situation
A device company with a next generation sports medicine product contracted with Emergent Clinical Consulting to determine if the current study criteria were aligned with their study enrollment estimates. 

Action Emergent Clinical Consulting conducted site qualification visits focused on reviewing the existing study criteria and the site’s available patient population based on the study inclusion and exclusion requirements.

Result After conducting site qualification visits, it was discovered that one of the study criteria that would have contributed to the primary endpoint was too restrictive to the patient population. It was determined that the original physical assessment would not have identified the target patient population and would have contributed patients with a more advanced degenerative disease. The protocol was amended prior to initiation to better identify the target patient population through a more accurate physical examination. This amendment ultimately reduced the time of active enrollment. By proactively introducing the amendment, the sponsor avoided an extensive enrollment phase, which would have contributed to approximately $1 million in additional fees for the Sponsor and an additional year to reach the market.