Case Study
Walking the Walk:
PSI’s site relationships in action
When a small biotech approached PSI to run a complex UC study, the sponsor’s concerns were clear: they wanted to streamline initial set-up, avoid complex vendor management, and overcome multiple operational challenges.
Number of Patients Screened: 390
Number of Patients Randomized: 210
Number of sites: 120
Total number of countries: 16 across 3 continents
Once PSI was awarded the study, we turned to our database of more than 4,000 global sites. To ensure fast site startup in the US, PSI identified the central IRB sites with both the right experience and the shortest contract finalization timelines. Our Site Qualification Specialists confirmed that sites were properly equipped to use study equipment, one of the most common delays in activation, before the Site Initiation Visit. We also worked closely with investigators to ensure activation timelines were met, helping us achieve the first site activation in just 3.5 months.
PSI works closely with various hospital networks and community health centers to broaden the pre-screening catchment area to reach smaller markets, allowing patients in more remote areas to enroll in trials and increase access for diverse populations. While the individual coverage areas vary from country to country, we work with vast global networks to support intra- and inter-hospital patient referral programs that meet each site's custom needs.
Using VISIONAL™, PSI’s proprietary data-driven feasibility and enrollment forecasting tool, to identify the best country mix and site profile for each study, we help minimize site burden and operational waste. By collating historical enrollment rates in the given patient population from both internal and external data sources, we can model and compare hundreds of enrollment scenarios within only a few minutes. Meanwhile, site teams can focus on identifying eligible patients and providing the best patient experience possible.
Communication with sites was crucial to enroll patients ahead of schedule. Once PSI identified the optimal sites for the trial, the Study Coordinator organized meetings with each site to discuss the study and each site’s immediate next steps. During the startup process, our CRAs began in-depth training and coaching with all relevant site staff on topics such as best practices for patient consent conversations, raising site awareness, study-specific tasks, and developing a site-specific patient flow to understand the referral process.
To facilitate open communication between the sponsor, our teams, and the sites, PSI also developed site-facing enrollment boosting materials, including eligibility worksheets, screening and enrollment flowcharts, and referral letters, which were provided to sites at initiation. These helped communicate patient entry criteria based on study parameters with each site.
Throughout the study, CRAs and other PSI study team members contacted sites weekly to maintain investigator motivation, track screening and enrollment, and investigate any challenges with low enrollment. This dedication helped PSI adapt quickly to significant challenges, including the impact of the COVID-19 pandemic, poor performance of a central lab leading to a change during the study, and challenges with the sponsor’s IP supplies vendor.
"I would call this team the A-Team of clinical trial execution.”
--Executive Vice President, Clinical Development
PSI CRAs are our site champions.
PSI’s Site Support Specialists provided additional tailored expertise and support. These team members are highly focused, therapeutically aligned individuals who have hands-on experience in the field. Guiding these multi-disciplinary teams, Site Support Specialists developed and maintained communication pathways between the combination of physicians/departments, lab specialists, and nurses to facilitate the smooth flow of referrals – and utilized a suite of proprietary PSI tools to ensure sites understood individual stakeholder responsibilities and key study strategies. Dedicated to building site relationships and understanding the dynamics of each site at the local level, they ensured that each site was supported and had the resources necessary to enroll patients effectively and maximize protocol compliance.
With the help of our CRAs, site support specialists, and other team members, PSI closed screening due to high volume even while sites had additional patients. We achieved 50% of the enrollment goal five weeks before the sponsor’s goal and completed enrollment more than five months ahead of schedule.
You have met and exceeded my hopes and expectations. I have seen so many challenges, and together we work through them. Speaking for myself and the entire team, we are grateful for this partnership and proud of what we have all accomplished together.”
