At the start of 2020, no one could predict what the next 12 months would look like. Resolutions of the New Year focused on goals, achievements, and the next big win. And quickly, those resolutions shifted – staying healthy and safe, keeping others healthy and safe, and working together to find a vaccine for a global pandemic that has effectively changed the pace of our entire world.
In clinical research and drug development, this change in pace was reflected, too. Whether organizations were running full steam ahead to focus on a COVID-19 vaccine, and or if they were running trials in other therapeutic areas, a shift in pace, in timeline, and accessibility was definite. Sites were on limited access, travel limitations and exposure risks were barriers to patients, and huge pushes towards virtualization, decentralization, and technology-heavy solutions were a key talking point. But through all of those obstacles, trials still needed to go on. Patients still needed access to care. And enrollment, still needed to deliver on time.
A Case Study: Delivering A Pivotal, Phase 3 Trial in 2020
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?
PSI CRO 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. The case study speaks for itself: even in the midst of a pandemic, we can find solutions to keep moving forward.
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 highlighted 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?
Call us today to discuss your pivotal trial needs!