In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.
|Articles|January 28, 2021
CROMSOURCE Consolidates Strategic Site Support Service
Advertisement
CROMSOURCE has announced the expansion of its Strategic Site Support Service that can be provided to sites participating in clinical research studies managed by CROMSOURCE on behalf of companies in the pharmaceutical, biotechnology, and medical device industries, or to clients and sites directly.
“As we see greater commitment within our industry to conduct patient centric research in which clinic visits can be done outside of regular working hours or remotely via telemedicine, we are seeing a need to flexibly support sites with strategic services provided to our clients or with the provision of staff directly at sites able to support this new way of working. Considering the effects of the global pandemic, provision of additional resources can also be the difference between sites being able to continue to deliver clinical research projects or having to suspend activities ” said Kerry Dyson, Chief Operating Officer at CROMSOURCE.
For more information, click
Advertisement
Related to this article
FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines
The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.
A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.
Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.
This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.
In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, outlines what it takes to move beyond transactional engagement and treat patient advocacy organizations as long-term partners in the science and the care.
In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.
As the life sciences industry continues to evolve, the ability to effectively manage and leverage preclinical CRO partnerships is set to become a defining characteristic of successful biopharma companies.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
The Execution Gap: Why Clinical Trial Infrastructure Has to Be Built Before AI Can Deliver
2
The Evolution of Preclinical CRO Strategic Partnerships: From Transactional Services to Value-Driven Ecosystems in 2026
3
Benchmarking Study Finds Clinical Trial Performance Is Shaped by Operating Model Design, Not Sourcing Strategy
4
How Clinical Teams Can Build Real Trust With Patient Advocacy Organizations
5