Rescue Study with Aggressive Timelines

Neurology Study

Rescue Study with Aggressive Timelines

SPONSOR

A successful and growing pharmaceutical company partnered with a well known fortune 500 pharmaceutical company. It was critical to bring this study back on track to keep the partnership in good standing.

PROJECT

A Phase 2 post herpetic neuralgia study. Previous CRO had monitored less than 50% of data in the initial 12 months, which was 6 months behind schedule. With just six months left in the timeline, the remaining data needed to be entered and monitored to meet the Database lock timelines.

CHALLENGE

How do you collect and monitor more than half of the data with less than a one third of the study timeline remaining? As a result of low data quality ProTrials identified that all study coordinators required EDC re-training to ensure optimal data quality. Furthermore, we needed to develop a plan to reconcile and collect all required documentation, specimens and equipment prior to data lock. This required an experienced regional monitoring team that could hit the ground running immediately. In addition, it required a ProTrials Project Manager that could quickly organize, communicate, work well under pressure and effectively manage all activities required to bring this study to a successful closure.

RESULTS

The first monitoring visit was conducted just 13 days after the kick-off meeting, and then 42 additional Monitoring Visits were conducted in approximately five and a half months. This resulted in the remaining 50% of the data being entered, monitored and cleaned in less than 6 months (as compared to the 12 months by the previous CRO). Thirty-four close-out visits were then completed in just 37 days.

Final queries were issued and resolved within three days, and the database was locked two days after eCRF sign-off. The original timelines for database lock were actually met one day early, and ProTrials was able to come in under budget for the successful completion of this important rescue study.