Early PMA Through Accelerated Trial Execution

Situation

‍

A global medical device company sought a trusted partner to execute a pivotal clinical trial for its closure device under an aggressive timeline extending from site selection through Pre-Market Approval (PMA) submission.

‍

HCC was selected for its expertise in clinical operations, regulatory strategy, and site management. Working in close collaboration with the sponsor, HCC implemented an agile, execution-focused approach to rapidly activate sites, maintain regulatory compliance, and drive efficient patient enrollment and data collection.

‍

‍Solution

‍

Through proactive planning, close collaboration, and disciplined execution, HCC consistently exceeded key study milestones.

‍

Patient enrollment outpaced projections, enabling Last Patient In (LPI) to be achieved ahead of schedule. This accelerated timeline supported database lock just three weeks after Last Patient Last Visit (LPLV), approximately one month earlier than planned.

‍

Simultaneously, Clinical Study Report (CSR) development was completed approximately six weeks ahead of schedule. Together, these efficiencies across clinical operations, data management, and regulatory activities significantly compressed the overall study timeline, enabling PMA submission approximately 2.5 months earlier than originally projected.

‍

Impact

‍

This case study demonstrates how agile clinical operations and strategic execution can accelerate the path to regulatory approval and market access. By surpassing enrollment targets and expediting critical milestones, including database lock and CSR completion, HCC enabled a PMA submission approximately 2.5 months ahead of schedule, delivering meaningful time-to-market advantages in a highly regulated environment.

‍

Key Outcomes

‍

• Operational Excellence: Executed the full clinical trial lifecycle within the sponsor's accelerated timeline, from site activation through PMA submission.

• Accelerated Enrollment and Study Execution: Exceeded enrollment expectations and achieved key milestones ahead of schedule, including early Last Patient In (LPI).

• Cross-Functional Efficiency: Seamless coordination across clinical operations, data management, and regulatory teams minimized delays and accelerated study completion.

• Regulatory Readiness: Maintained rigorous quality and compliance standards while delivering a PMA submission approximately 2.5 months ahead of plan.

‍

Business Outcome

‍

This engagement demonstrates how strategic collaboration, proactive planning, and disciplined execution can significantly accelerate development timelines. By compressing critical study milestones and enabling an earlier PMA submission, HCC helped reduce development risk, optimize resource utilization, and expedite patient access to an innovative medical device.