Applied Clinical Trials
Tufts CSDD
What are the most important factors in selecting a Phase I service provider?
That depends how we look at the data from ISR's latest report, "2012 CRO Quality Benchmarking—Phase I Service Providers." Of the 61 executives responsible for Phase I study conduct and outsourcing, more selected "prior positive experience with a service provider" than any other attribute as the single most important driver of selection. However, when asked to indicate their top five drivers of selection, more respondents chose "access to patient populations" among their top five than any other attribute.
Attributes that fuel service provider selection.
This is notable considering the other 20 attributes respondents had to choose from are historically critical skills such as therapeutic expertise, project management, timelines management, and even the experience of the Phase I unit's lead investigator.
For now, historical relationships will continue to get a Phase I provider invited to bid.
Going forward, the ability to demonstrate patient—not just healthy volunteer—recruitment capabilities will make the difference between a win and a loss.
—Industry Standard Research, www.ISRreports.com.
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.