Navigating Choppy Waters

A U.S.-based, development-stage pharmaceutical company (the “Sponsor”) leveraged a relationship with an industry consultant to find a partner organization that could manage a new study within a particularly ambitious timeframe. The Sponsor chose an organization whose services were familiar: Catalyst Clinical Research and its Catalyst Flex solution’s multi-therapeutic global resourcing and functional service capabilities.

The study would assess the efficacy of an anti-vomiting and anti-nausea compound in humans. The Sponsor enrolled over 500 subjects in a single month to test the compound during a series of boat rides by being assigned either a nasal gel or a placebo. The Sponsor managed all site activity, with the data management and safety databases managed by Catalyst Flex resourcing.

Thanks to a resourceful approach rooted in the existing relationship between the Sponsor and Catalyst Flex, the study was fully executed in only 119 days (about 4 months) from Institutional Review Board (IRB) approval to database lock.

Catalyst Flex was engaged to build an electronic data capture (EDC) system database and monitor subject safety. Listening to the Sponsor’s needs, Catalyst Flex demonstrated commitment through the appointment of an experienced study team that consisted of a veteran project manager, data manager, coding specialist, safety manager, and programmer; each were well-versed with TrialKit EDC. The programmer’s familiarity with the platform was complemented by building a similar database for the Sponsor on a prior study. The programmer worked closely with the Sponsor to outline the differences between the two studies and helped lead the Flex team to deliver the solution in record time. The Sponsor set up multiple teams at the site to enter and review the data. The Catalyst Flex data manager and coders reviewed and confirmed the data, working closely with the Sponsor teams to make it possible to lock the database in record time.

The partnership resulted in successful study completion ahead of planned timelines, and high-level results confirmed that the desired study endpoints were met. The Sponsor obtained data on its 500+ enrollees, entered all data into the EDC system, and completed monitoring in record time. Catalyst Flex resources reviewed the data and closed all queries bringing the study from IRB approval to database lock in only 119 days. In addition, the Sponsor was pleased with its additional investment in a project manager who would oversee the Catalyst Flex resources, ensure quality and timely deliverables, and ease client burden.

This outcome was made possible, in part, by Catalyst Flex’s history with the Sponsor and by leaning into the TrialKit EDC design from a past project. The Sponsor’s study design, study team, and strategic system selection—paired with Catalyst Flex’s data management team and experience—resulted in quick, efficient, and accurate data entry and review. As a result, many subjects were enrolled, assessed, and completed in a brief period.

The partnership was repeat business between Catalyst Flex and the Sponsor. Catalyst Flex resourcefully exhibited the company’s core values of flexibility, listening, commitment, collaboration, and learning to support the unique protocol and the study’s swift, clean data review.