Based on an initial implementation that showed StudyTeam would reduce total enrollment time by an average of 25 days per clinical trial and reduce non-enrollment in clinical trials by 25%, Amgen selected StudyTeam as its enrollment performance management platform for its whole portfolio.
Today Amgen uses StudyTeam in all its Phase I–IV trials, including:
more patients enrolled per site, per month with StudyTeam*
less likely to be zero-enrollers when sites are using StudyTeam*
of sites prefer StudyTeam over other methods to manage enrollment*
“StudyTeam gives us visibility into activity at a site enabling us to support and partner with sites to deliver tailored enrollment tools to get more patients into these pivotal trials.”
—Dylan Rosser, executive director of global development operations, Amgen
“I have been a clinical research coordinator for twelve years in Spain and I have never seen such a complete system. It’s actually perfect!”
—Clinical research coordinator, Spanish research site using StudyTeam for Amgen trials
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AstraZeneca is prioritizing the site experience and the patient experience in its breast cancer clinical research program. By empowering sites with easy-to-use technology that allows sites to manage patients across all trials, AstraZeneca helps sites overcome the traditional challenges of moving candidates effectively through the enrollment funnel. And as the sponsor, AstraZeneca gains real-time visibility into patient enrollment to make quick, informed decisions on key issues that reduce site burden, improve candidate identification, and ultimately accelerate enrollment timelines.
“We now use StudyTeam to track patient recruitment and patient enrollment for all of our studies,” said Katherine Wall, senior data manager at clinical research site Redlands Hematology Oncology in Redlands, California. “StudyTeam is a huge game changer for us to track all our patients in the solid tumor and hematologic malignancy trials that we’re participating in, and we’re now able to be even more efficient with our prescreening, thanks to StudyTeam. We’re grateful for sponsors like AstraZeneca that focus on providing sites like ours the solutions we need to enroll effectively.”
Sites using StudyTeam with AstraZeneca randomize more patients per site per month and provide overwhelmingly positive feedback
100% of sites using StudyTeam in its trials choose to do so for subsequent studies
Sites using StudyTeam with AstraZeneca randomize more patients per site per month and provide overwhelmingly positive feedback
100% of sites using StudyTeam in its trials choose to do so for subsequent studies
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[Nicole] Sheetz, [clinical systems director, Eli Lilly and Company,] notes an innovative cloud-based solution is enabling this trial and other trials taking a decentralized approach. The solution is called StudyTeam. The software was used to connect potential trial participants who are distributed across long-term care facilities. Individuals can join the wait list for the trial. A study team would manage recruitment on the ground and take potential participants through the pre-screening and enrollment process.
StudyTeam allows all patient information to be stored in one place. The software also allows study teams to understand what volume of resources might be required at a particular facility.
“One facility might have 20 or 80 persons on the wait list,” says Sheetz. “We need to know how many people and what equipment will be required at each facility in those first 48 hours. The software also allows personnel back at Lilly to be able to look at enrollment data and recruitment data to troubleshoot potential issues and modify the approach used at a particular facility. Our approach could vary based on the facility or region of the country.”
Digitizing paper documents is also important. On-site staff might still be using paper, but many investigators work remotely and still need to access data immediately. Therefore, any paper documents generated by site staff must be digitized immediately. “That has been one of our core technology needs,” says Namvargolian. “We can now scan and upload the documents quickly.”
Read the full article in Clinical Leader
Merck uploaded inclusion/exclusion criteria to StudyTeam so its sites could pre-screen patients directly in the system as they reviewed patient records. As Merck tracked the speed of enrollment in real time, it made informed adjustments to protocols of several studies to accelerate timelines along the way.
Seeing StudyTeam’s immediate impact for accelerating enrollment, Merck decided to equip its sites with StudyTeam’s visit management capability. Without an automated visit management tool, Merck’s sites had been manually coordinating visits, often with complicated spreadsheets.
To make visit management easier, StudyTeam brings a sponsor’s protocol into the site’s workflow, and OneStudyTeam configures the system for all sites to have access to StudyTeam’s Visit and Imaging Calculator. With this capability, site staff can properly forecast when a visit needs to occur and schedule it in one place. Visit management in StudyTeam gives site staff automatic visibility into the date, time, and purpose of visits for each patient.
of Merck’s sites that choose StudyTeam used it again on subsequent Merck studies
of sites on Merck studies choose StudyTeam over their current process
Merck and OneStudyTeam are scaling their work together and have begun rolling out StudyTeam broadly to Merck’s global oncology portfolio, involving partnership across 41 countries
“StudyTeam is a tool coordinators dream about. This is such a great system. It has everything we need in one easy-to-use place. We usually struggle to keep track of this information. Thank you so very much for bringing this system into my life.”—Clinical research coordinator, private practice, US
“StudyTeam makes our Excel sheet look archaic. It's so clean and straightforward. It's a one stop shop for everything we need to track.”—Clinical research coordinator, hospital, Canada
“StudyTeam is a really, really nice application. It will for sure reduce my workload and diminish the paper loads. No need to have a different log for each trial now, I can use the StudyTeam patient log for my other trials as well.”—Clinical research coordinator, AMC, Belgium
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93% of Merck's sites that choose StudyTeam used it again on subsequent Merck studies
Read MoreWhen designing StudyTeam, OneStudyTeam examined how technology was applied in other industries to make two-way communication easier. For clinical trials, communication happens between a many-to- many, two-sided network: sponsors and sites. StudyTeam brings these two stakeholders onto a common platform and embeds technology into the way they work together, just like the many platforms people use to reserve a table for dinner, book flights, or order grocery deliveries.
Excel spreadsheets and site-specific systems are siloed from sponsors and create more work for sites, so Sanofi decided to leverage StudyTeam. The platform helps sites do their work and brings sites’ workflows online for sponsors to see. Sponsors also upload protocols directly into StudyTeam so sites have everything they need.
This approach dramatically reduces the effort required for sites to share the information Sanofi needs. Deploying StudyTeam reduces site burden, which means Sanofi doesn’t force new technology on sites that don’t want to use it. Not every site wants to use StudyTeam—sites maintain the ability to choose what technology they use. The vast majority choose to use StudyTeam because it saves time.
of sites chose to use StudyTeam over other tools for managing recruitment and enrollment
of sites chose to use StudyTeam for one Sanofi trial choose to use it again for additional Sanofi trials
of sites chose to use StudyTeam for Sanofi trials use it again for trials with other sponsors
more patients enrolled per site, per month for sites using StudyTeam
Sites are 14% less likely to be zero-enrollers
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Learn how StudyTeam exceeds Sanofi's expectations when it came to measuring success by how useful it was for both sites and the sponsor.
Read MoreMore patients were enrolled by sites that used StudyTeam
Of sites that used StudyTeam opted to use it again on their next trial
Of the sites that opted in to use StudyTeam, 99% chose to use it again on their next study
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Global Sponsor eliminates site burden, while gaining earlier visibility into site performance and pre-screening data
Read MoreStudyTeam’s Trial Board made it easy for the sponsor to track oncology patients over long periods of time and during lengthy medication washout periods. This ensured that they were able to enroll every enrollable patient.
Because sites chose StudyTeam overwhelmingly over other methods for tracking recruitment, prescreening, and enrollment, the sponsor had access to comprehensive real-time enrollment funnel data.
StudyTeam’s Visit Window Calculator made it easy for sites to schedule patients within visit tolerances. This saved sites immense amounts of time and reduced protocol deviations for the sponsor.
more patients were enrolled by sites using StudyTeam than sites that did not
of sites chose to use StudyTeam over their prior solution for managing patient enrollment
of sites that chose to use StudyTeam added another trial from the Sponsor’s portfolio
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In this case study, learn how The Head of Oncology and her Clinical Operations team were able to overcome these challenges by deploying StudyTeam globally
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