Amgen, a California-based biopharmaceutical company, has expanded adoption of Reify Health’s StudyTeam cloud-based patient management software across its global research portfolio. The tool is designed to help sites and sponsors streamline patient recruitment and enrollment, and improve collaboration and communication among locations.
Originally, Amgen deployed the software to a number of trials across multiple indications, reportedly in an effort to reduce the amount of manual work involved in recruitment, and to automate sharing of information between sites and teams. After favorable results, the company designed to expand use of StudyTeam to all of its therapeutic area programs.
After broadening the use of StudyTeam at its company, Amgen reportedly has experienced improvements across key measures of enrollment efficiency, including:
- patients enrolled per site per month
- reduction in zero-enroller sites.
Outsourcing-Pharma spoke with a Reify Health representative, who explained with protocols becoming increasingly complex, and sponsors tracking more patient data points than ever, ability to effectively and swiftly identify the inclusion and exclusion criteria that may need adjustment is key to trials running smoothly and within budget.
“In the traditional model, where sites report pre-screening data manually using pre-screening logs, these insights often come with substantial delays - oftentimes weeks or months,” they said. “With StudyTeam, sites are able to systematically and quickly track pre-screening data as they carry out recruitment efforts and automatically share key insights with sponsor."
The spokesperson told us of one client’s rare disease trial, sponsored by a top global firm. StudyTeam reportedly enabled insights into inclusion/exclusion criteria that led to a rapid protocol amendment that made it possible for the trial to begin enrollment 29 days earlier than originally anticipated.
Dylan Rosser, executive director of global development operations at Amgen, said the success of any clinical trial depends on the ability on effective, efficient patient recruitment.
“Investigational sites have an incredible workload to manage; not only are they recruiting into clinical trials, but they are treating their entire patient population with a fixed resource,” he said. “StudyTeam positions itself in the sites’ workflow allowing them to visualize their patient population and their patients’ suitability for any given protocol. For sponsors, it gives us visibility into activity at a site enabling us to support and collaborate with sites to deliver tailored enrollment tools for these trials.”
Reify Health offers StudyTeam to clinical research sites, enabling them to centrally manage and track an array of recruitment and enrollment activities and information, including pre-screening activity, recruitment progress, and the impact of inclusion/exclusion criteria on enrollment. Sponsor trial teams are then able to access information securely to view site-by-site pre-screening status and activity, monitor recruitment strategies, and take earlier action (i.e. protocol amendments, deploying backup sites, and reallocating recruitment budget).