Quartesian Data Expertise Rescues Study By a Top 3 Generics CRO

How a Quartesian FSP Partnership Helped a Leading CRO Save the Day

The Challenge: Enrollment and Database Challenges Threaten Study Outcome

A top three generics CRO needed an FSP partner to assist with data management, statistical programming, and medical writing for a generics study. Unforeseen circumstances began to unfold, casting uncertainty over the IP’s future — and, eventually, turning the project into a rescue operation.

Enrollment delays tightened the study’s timeline by two months, introducing the first challenge to the CRO’s program. Compounding the problem were database reconciliation issues. The study leveraged three database systems — RAPIDS, ERT, and Medrio — and entries weren’t consistent across all three. The CRO’s RAPIDS IRT system and ERT’s spirometry database contained subjects that were not present in the Medrio database, leading to premature closure of study sites.

It was beginning to look dire when the study failed to meet the equivalence criterion in both co-primary endpoints, despite meeting its superiority endpoint. Enter Quartesian.

The Solution: Data Sleuthing and Fast Action to Solve for Success

Straight away, the Quartesian data management team noticed database queries were aging and failing to resolve. Quartesian brought it to the CRO’s attention, then took the lead in identifying the root causes. Quartesian collaborated with the CRO’s team of clinical research associates to identify low-enrolling sites and determine whether they were at risk of closure. Then, Quartesian targeted those sites for source data verification and monitoring activities to ensure data was cleaned before closure, providing round-the-clock resources from then until final database lock.

Meanwhile, the Quartesian medical writing team finalized the clinical study report (CSR) shell as early as possible. This would minimize the time spent completing documentation and M5 submission once the final Tables, Lists, and Figures (TLFs) were released.

Finally, Quartesian’s statistician recommended a reanalysis of the study. Though the first analysis concluded that the study failed to reach its equivalence criterion endpoints as outlined in the protocol, Quartesian suspected that by rooting out the source of the database resolution error, then troubleshooting the issue, they’d yield a more accurate outcome — even favorable.

The Outcome: Partnership Rises Above the Odds, And the Study Passes

Through a series of investigations, Quartesian was able to determine the reason for the discrepancies in the databases: both the ERT and RAPIDS databases contained false subject entries that didn’t correspond to actual study participants. Quartesian worked with the CRO’s CRAs to resolve the issue, eventually reconciling Medrio to RAPIDS, and provided the necessary knowledge sharing to avoid similar database issues in future studies.

After a reanalysis of the resolved data, both the equivalence and superiority endpoints were met, and the study passed — adding yet another success to the CRO’s already impressive generics portfolio. To round out the triumphant final lap of the study, Quartesian’s medical writing team finalized the M5 documentation quickly enough to shave a month from the extended timeline, minimizing delays caused by enrollment issues.

It came down to the wire, but the strength of both the CRO’s IP and Quartesian’s data expertise rose above the challenges to ensure a successful outcome — all while proving the power of partnership.

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