During the eight weeks the study was halted, Quintiles worked to keep investigators motivated by carefully and thoroughly explaining the protocol changes and providing regular communications and updates.

The result is that, even with the protocol amendment, Quintiles met the enrollment deadline in eight months rather than the targeted ten months — a full two months early. This positive outcome ultimately contributed to a successful marketing application and facilitated the sponsor in reducing the timeline to market — a major benefit to patients and the sponsor, alike.