OneStudyTeam
12 Case Studies
A OneStudyTeam Case Study
Top-10 Sponsor Clinical Company, a top-10 sponsor running a Phase 3 trial with more than 300 sites, needed better visibility into what was slowing enrollment and which inclusion/exclusion criteria were causing pre-screen failures. With trial completion gating NDA submission and enrollment expected to take two years, the sponsor turned to OneStudyTeam and its StudyTeam platform to gain earlier insight into recruitment issues.
By deploying StudyTeam across its sites, OneStudyTeam helped the sponsor collect data on 600 patients in just 6 weeks and pinpoint the criteria driving most pre-screen failures. The sponsor used this real-time analysis to amend inclusion criterion #4, revisit patients who had previously failed pre-screening, and accelerate enrollment beyond timeline goals, while also using protocol amendment impact analysis to guide future trial design.
Top-10 Sponsor Clinical Company