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Situation
A U.S.-based, global company sought a trusted partner to execute aclinical trial for its closure device product. The project was highlyaccelerated, with an aggressive timeline spanning site selection throughPre-Market Approval (PMA) submission.
HCC was selected for this exceptional opportunity to collaborate withthe sponsor, bringing its expertise in clinical operations, regulatorystrategy, and site management to ensure success under tight timelines.Leveraging a focused and agile approach, HCC rapidly activated sites,maintained strict adherence to regulatory requirements, and drove efficientpatient enrollment and data collection.
Solution
Through close partnership, proactive communication, and disciplinedexecution, HCC drove the clinical program, consistently outperforming itsplanned milestones. Key deliverables were achieved ahead of schedule,reflecting the strength of collaboration, strategic execution, and operationalefficiency.
Subject enrollment was completed in advance of projections, with LastPatient In (LPI) achieved earlier than anticipated. This momentum enableddatabase lock to occur one month ahead of plan—just three weeks following LastPatient Last Visit (LPLV).
In parallel, Clinical Study Report (CSR) development was accelerated byapproximately six weeks. As a result of these aligned efficiencies acrossclinical, data management, and regulatory functions, the overall timeline wassignificantly compressed, enabling the Pre-Market Approval (PMA) submission tooccur approximately 2.5 months ahead of the originally projected schedule.
Significance
This success storydemonstrates the impact of a highly coordinated, agile clinical operationsstrategy in accelerating time-to-market for a regulated medical device. Byexceeding enrollment targets and compressing key milestones—including databaselock and Clinical Study Report completion—HCC enabled a PMA submissionapproximately 2.5 months ahead of schedule, a meaningful achievement in atightly constrained regulatory environment.
