PRA's Strategies Impress Client

A randomized, double blind, placebo-controlled study of the safety and tolerability of study Drug and its effects on biomarkers in subjects with coronary artery disease.

PRA was awarded a global Phase II safety and tolerability study of a drug with a novel action for the treatment of coronary artery disease. The study, which involved more than 130 sites and 700 patients, encountered many chal­lenges due to last-minute design and operational changes and tight timelines. Regardless, PRA completed the study successfully, thanks to our project team’s determination and innovation.

This study required PRA to achieve milestones under extremely challenging timelines and operational logistics. For example, the team had to execute a late requirement to fully lock 90% of the subjects 5 months earlier than originally planned. This initiative required fast implementation of a patient profile review process, which also had not been previously required, and reconciliation across 6 vendors. The revised schedule put extra pressure on team members, who had to work nights and weekends for months. Site relationships were strained, and there were difficulties with reviewing profile data that was still being monitored, collected, and cleaned. In addition, profile review cohorts overlapped, and each cohort required specific data collection/query cycles in conjunction with case adjudications. This mandated a complex orchestration of resourcing, CRF/query/profile tracking, vendor reconciliation, and both internal and site communications. As a result, changes in the timing of any step required numerous communication and planning adjustments to mitigate risks that would otherwise jeopardize the aggressive timelines that had been introduced mid-study.