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The EY Clinical Trial Fast Lane solution accelerates clinical trial site activation to bring novel therapies to patients faster while reducing costs and resource needs for sponsors and sites.
Clinical trial site activation timelines are a leading indicator of overall clinical trial performance, yet they remain a leading cause of delays in clinical development. Long trial startup timelines can delay or prevent patients from accessing novel therapies, exacerbate challenges in clinical trial enrollment and retention, and present significant opportunity costs for industry sponsors and clinical trial sites alike.
Solution benefits
The EY Clinical Trial Fast Lane solution accelerates high-priority clinical trials, delivering up to a tenfold reduction in site activation timelines, which enables sponsors and sites to:
Execute trials faster to solidify progress against strategic, operational and financial goals
Deepen strategic partnerships by prioritizing key sponsor-site relationships through differentiated activation timelines
Improve engagement and personnel satisfaction through improved, streamlined site activation processes
Our EY Clinical Trial Fast Lane concierge and functional support team members bring deep knowledge of clinical trial site operations, integrating directly into site activation functions to drive progress excellence and execute key study startup milestones.
Clinical trial sites that use our solution receive hands-on support to optimize and accelerate key site activation milestones, such as:
Clinical trial agreement development and negotiation
Coverage analysis
Clinical trial budget development and negotiation
Regulatory reviews, including submissions and follow-ups to institutional review boards (IRBs) or other safety committees
Study calendar builds and/or treatment plan builds
Coordination of site trainings, system access and the site initiation visit
EY Clinical Trial Fast Lane has delivered significant reductions in US site activation timelines:
* Net-new trials measured from completion of site feasibility review through to site activation. EY Clinical Trial Fast Lane involved from start. Days are counted as working days. Backlog trials measured from start of EY Clinical Trial Fast Lane site engagement through to site activation. Activation “struggling” prior to EY engagement. Majority of EY Clinical Trial Fast Lane sites are US academic medical centers and/or NCI-designated (comprehensive) cancer centers.
EY Clinical Trial Fast Lane has successfully accelerated clinical trial activation for sites across the United States, averaging 44 days for net-new trials supported by EY from the beginning, and 51 days for backlogged trials that had been pending activation at the site prior to being accelerated via Fast Lane. To date, our team has supported 115 trials in Clinical Trial Fast Lane across 68 sponsors.
Why EY
We accelerate clinical trial activation, leveraging our strong experience and understanding of clinical trial operations at the intersection of the health and life sciences sectors and across the R&D continuum.
FAQs
EY Clinical Trial Fast Lane services can be applied to most clinical trials and therapeutic areas. We have supported Phase I, Phase II, Phase III and device trials, and most trials we have supported span oncology, cell and gene therapy, and cardiovascular studies. We work with you to identify the trials that matter most and understand where EY Clinical Trial Fast Lane services will have the biggest impact.
We support many types of clinical trial sites, including academic medical centers and health systems, community health systems, and cancer centers. There are over 35 sites currently using our EY Clinical Trial Fast Lane solution and services, and this number continues to grow.
We are actively seeking to expand our services in other regions beyond US clinical trial sites. If these services are of interest, please reach out to our team to learn more.
Clinical trial activation requires extensive, cross-functional collaboration across the site. Our unique concierge team brings deep knowledge of how sites operate to navigate these complexities, and it provides hands-on support to site personnel to help them deliver significantly accelerated startup timelines.
In the absence of a true industry standard for calculating clinical trial activation timelines, we generally follow the National Cancer Institute methodology such that the start date is the date of submission to the protocol review and monitoring committee (or, for non-oncology trials, an equivalent feasibility committee), and the end date is the date of site activation. We align with you on how EY Clinical Trial Fast Lane timelines will be calculated and which activities our team will support.
Our preferred model is to develop a performance-based fee system where the cost to implement EY Clinical Trial Fast Lane services is tied directly to how successful we are at accelerating site activation.
Please feel free to reach out for specific details.
We are piloting several solutions to support the acceleration of patient recruitment and enrollment. If these services are of interest, please reach out to our team to learn more.
Our team’s extensive experience across the R&D ecosystem informs our understanding of how clinical trial sponsors and sites work today, including collaboration with other key players in the clinical trial startup process (e.g., commercial IRBs, CROs). We bring deep knowledge of clinical trial site operations to predict and proactively mitigate against common causes of activation delay.
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