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.
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.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.