Case Study: Delivering a Global Pivotal, Phase 3 Trial in 2020


Staff Writer

Design: Adaptive, Randomized, Double-blind, Double-dummy, Prospective Trial 

Phase: III 

Drug Class: Antibiotic 

Indication: Complicated urinary tract infection (cUTI)

Geography: 15 countries across three continents: USA, Bulgaria, Czech Republic, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, Ukraine, South Africa 

Sites: 101 sites, more than 95% enrolled patients 

Simply put, delivering trials is what we do. It’s our expertise – it’s what we’re dedicated to, and it’s what our teams are built for. But, not so simple, is the trial itself. In fact, when has an Adaptive, Randomized, Double-blind, Double-dummy, Prospective Trial been easy? When has a pivotal, phase 3 program been defined as “simple” by any means?

At PSI, we can do hard things. And that’s how we ran this study in 15 countries, across 3 continents, at more than 100+ sites. Take a look at the video below to learn more about the study, and see the hidden dimensions behind what it takes to enroll.

We completed enrollment on time, with Last Patient In (LPI) occurring during the peak of the first COVID-19 wave. Because PSI invests significant time and resources to build close site relationships, our CRAs are considered as ambassadors of the sites – they go further than what is typical across the industry. This means that sites want to work with PSI, they prioritize our studies, and we understand their preferred methods of working. In turn, we’re able to complete enrollment on-time, even in the midst of a global pandemic.

We Can Do Hard Things

PSI enrolled the described trial at a rate 23% higher than industry metrics in the same indication, while achieving all key milestones on schedule.

To say that this wasn’t easy would be an understatement.  Where did anyone see an easy phase III trial lately:  timelines slip, vendors get acquired, standards of care change, interest dwindles, competition doesn’t stand still…the list goes on and on.  These studies are meticulous, and require a great amount of time and attention. 

Making the Difference: The Right Team

It takes an inordinate amount of dedication, uncommon commitment to owning contractual promises and a team that’s stable, dependable and focused on the right things at the right time.  Do you want to work with a team like that?

Contact us today to discuss your pivotal trial needs!