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’s global development operations and trial teams knew that in order to affect change broadly across their research portfolio they would need to rethink the way they worked with sites to track and manage pre-screening activities. They needed a solution that:
Sites adopt broadly and use regularly as part of their daily enrollment management processes
Was flexible enough to span all therapeutic areas, trial designs, and global regulations
Delivered secure, accurate, and actionable information
Provided measurable benefit to key enrollment metrics
Delivered measurable benefits over previous solutions
Amgen first deployed StudyTeam to help measure and drive site enrollment efficiency across a small set of trials. An analysis showed that StudyTeam:
Would reduce total enrollment time by an average of 25 days per clinical trial
Would reduce non-enrollment in clinical trials by 25%
As a result of this analysis, Amgen selected StudyTeam as its solution for enrollment performance management and moved toward portfolio-wide adoption of StudyTeam for all of its Phase 1 through 4 clinical trials. Both Amgen and Reify have committed resources and laid out strategies to aid in StudyTeam’s expansion within Amgen. To date, Amgen has expanded StudyTeam to:
28 clinical trials spanning 15 products and 15 indications, and counting
35 countries, and counting
700+ research sites, and counting
Throughout the phases of deployment at Amgen, StudyTeam has and continues to exceed its KPIs related to site utilization, enrollment efficiency, and cost savings.
A number of sites that participate in Amgen trials have adopted StudyTeam over the manual pre-screening logs they previously used. Site users cite StudyTeam’s ease of use and value as an enrollment solution, especially when compared to manual pre-screening logs that act solely as data collection tools, creating additional work.
Sites are also able to manage pre-screening and enrollment across various channels, including both patients from their own practice and outside patient referrals, all of which feed directly into StudyTeam for a unified view of recruitment. This allows them to share valuable pre-screening information directly with Amgen in real time.
Amgen’s trial teams utilize this information to make early and informed decisions about site management, recruitment tactics, and protocol design, which has led to improvements on enrollment performance.
Gain insights and control that you’ve never had before. A clinical trial enrollment software that both sponsors and sites will love.