A mid-sized multinational biopharmaceutical company opted to internalize the study management and execution of their Phase Ib/II multicenter oncology program. The original objective was to enroll 120 subjects among 18 sites, across 6 cancer types. The Sponsor chose Catalyst as their clinical monitoring partner to augment their internal team.
As a result of positive treatment outcomes, patients continued in the trial for significantly longer than originally projected, creating a large data backlog that required source document verification. A study that was initially forecasted to complete within 16 months, created both opportunities and challenges for the Sponsor including multiple protocol amendments, expansion of study centers into Europe, and expanding patient enrollment three-fold in specific tumor types. The initial CRA monitoring team needed to scale to meet the realities of this high priority program.