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How Leading Biopharmas Use Technology to Speed Up Enrollment

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Amgen

Amgen's Objective: Accelerate Enrollment Time

Like many other biopharmaceutical sponsors, Amgen and its global research sites were relying on manual processes—such as emailing or faxing spreadsheets containing de-identified information—to track pre-screening activity at sites.The manual and fragmented nature of this process led to inefficiencies, reduced sponsor visibility into real-time pre-screening trends, and ultimately, enrollment challenges. As a consequence, any required decisions to change enrollment strategy were often made further into the enrollment process—causing delays in study execution. Amgen wanted to accelerate enrollment time and increase efficiencies.

How StudyTeam Helps Amgen and Its Sites

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:

  • 26 clinical trials spanning 15 products and 15 indications, and counting
  • 20 countries, and counting
  • 1000+ research sites, and counting

Key Results

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*

*Note: these results are for 26 Amgen studies across 1,019 sites in 20 countries as of 22-Feb-2021

What Amgen's Sites Say about StudyTeam

“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

Read the full Case Study

Amgen Increases Efficiencies in Working with Sites and Improves Enrollment Across Its Global Research Portfolio

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AstraZeneca

AstraZeneca's Objective: Real-time Visibility into Patient Enrollment

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.

How StudyTeam Helps AstraZeneca and Its Sites

“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.”

Key Results

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

Key Results

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Sites using StudyTeam with AstraZeneca randomize more patients per site per month and provide overwhelmingly positive feedback

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100% of sites using StudyTeam in its trials choose to do so for subsequent studies

Read the full press release

Reify Health Powers Patient Recruitment and Enrollment Across AstraZeneca's Extensive Breast Cancer Clinical Trial Pipeline

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Eli Lilly and Company

How StudyTeam Helps Eli Lilly and Company and Its Sites

The following is an excerpt from a Clinical Leader article, “Lilly, Care Access Take COVID Trial Directly To Patients,” published December 10, 2020.

[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 by Reify Health. 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

Lilly, Care Access Take COVID Trial Directly To Patients

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Merck

With intense competition among sponsors for high-performing research sites, Merck wants to stand out as a sponsor of choice. As part of its Global Trial Optimization mission, Merck provides sites with high-value operational insight, parameters for study conduct, and recruitment and retention strategies and tactics.

These objectives address the entrenched daily and long-term problems sites face. As research sites recruit and enroll patients for a trial, they contend with immense administrative burdens, all while providing care for their patients. Ultimately, when sites face too many burdens, information falls through the cracks, and sponsors lose visibility of critical data.

How StudyTeam Helps Merck and Its Sites

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 Reify Health 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.

Key Results

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 Reify Health are scaling their work together and have begun rolling out StudyTeam broadly to Merck’s global oncology portfolio, involving partnership across 41 countries

What Merck's Sites Say about StudyTeam

“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

Read the full case study

Merck Reduces Site Burden to Enroll Oncology Trials with StudyTeam

93% of Merck's sites that choose StudyTeam used it again on subsequent Merck studies

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Sanofi

Before using StudyTeam, Sanofi requested periodic updates through a template with everything they wanted to know. This process involved a trial monitor reaching out to each site through email and phone calls, which added work for sites. Sites were responsible for both patient recruitment and reporting on recruitment. The cumbersome manual reporting process took time away from patient care and didn’t help sites reach recruitment goals.

Sanofi recognized that the process was not optimal and identified problems in the enrollment process: information silos, asynchronous communication, and extra reporting for sites. Having sites report manually on patient enrollment reduced efficiency, limited the information Sanofi received to outputs rather than visibility into the enrollment process, and left errors and gaps in the full picture of enrollment. Sanofi sought a mutually beneficial solution—they wanted to see sites’ workflows during the enrollment process while making the whole process easier for sites.

How StudyTeam Helped Sanofi and Its Sites

When designing StudyTeam, Reify Health 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.

Key Results

“With StudyTeam we saw measurable impacts on both enrollment time and costs, while making our sites happy.”—Laura Kling, director, digital innovation, Sanofi

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

*Data is from seven Sanofi trials across 465 sites; StudyTeam can report on 100% of sites through data integration; data collected from multiple trials, multiple therapeutic areas, and multiple continents

What Sanofi's Sites Say about StudyTeam

"This system is fantastic! I wish every sponsor used it; it would be very helpful for every single protocol we have."—Diana Soares, research coordinator, Hospital Infante Dom Pedro, Portugal

"This system is amazing. Before StudyTeam, I’d track my patients on post-its that I’d stick on my computer. Those are so easy to lose and you can’t take them out of the office. I like starting my day with a cup of coffee and checking StudyTeam."—Research coordinator, US site, Pennsylvania

Read the full case study

Sanofi Enrolls 21% More Patients with StudyTeam™

Learn how StudyTeam exceeds Sanofi's expectations when it came to measuring success by how useful it was for both sites and the sponsor.

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More Top 10 Sponsors

(De-identified)

Sponsor A

The Sponsor's Objective: Reliably Predict Enrollment Timelines

A top-10 global pharmaceutical company that had previously worked with a large CRO and invested millions in the effort to create a solution that would improve the predictability of their enrollment timelines. This costly solution proved inconsistent and was not adopted by their research sites, ultimately resulting in its failure.

How StudyTeam Helped the Sponsor and Its Sites

StudyTeam provided the Sponsor with real-time visibility into site activity and with access to pre-screening data that enabled the Sponsor to quickly take action that would accelerate enrollment. These factors, among others, contributed to the increase in enrollment performance.

By automatically de-identifying and sharing this pre-screening, screening, and enrollment data that sponsors need, StudyTeam also reduced unnecessary status calls and emails, and eliminated the duplicative work of filling out traditional patient logs that distract site personnel from moving patients through the enrollment process.

Key Results

More 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

What the Sponsors Sites Say about StudyTeam

“Our entire team uses StudyTeam daily to document, monitor and report on enrollment activities. It is user friendly and the customer support from Reify Health is outstanding, the best we have encountered for ANY system. We have abandoned all other tracking solutions for our recruitment.”—Ellen Dobrusin, clinical research coordinator

Read the full case study

Top-10 Sponsor Enrolls 22% More Patients with StudyTeam™

Global Sponsor eliminates site burden, while gaining earlier visibility into site performance and pre-screening data

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Sponsor B

The Sponsor's Objective: Understand Patient

The head of oncology and her clinical operations team at the sponsor company were facing increasing competition for patients in their oncology trials. The complexity of the protocols and the length of the trials made it difficult to track patients longitudinally prior to randomization, leading to major blind spots in the patient recruitment and enrollment funnel.
The sponsor also assumed that their sites were working on their studies, but lacked the data to know which sites were successfully recruiting and pre-screening and which were not. They found that few candidates were actually hitting the IxRS system.

How StudyTeam Helped the Sponsor and Its Sites

Longitudinal Patient Visibility

StudyTeam’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.

Near Universal Site Uptake

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.

Complex Schedule Tracking

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.

Key Results

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

Read the full case study

Top-10 Biopharma Improves Enrollment & Efficiency Across Complex Oncology Trials

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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