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|June 1, 2011
- Applied Clinical Trials-06-01-2011
- Volume 20
- Issue 6
Applied Clinical Trials Digital Edition - June 2011
CRO/SPONSORS : Integrated Drug Safety Archiving in the United Kingdom Language and Culture in Global Trials INFORMATION TECHNOLOGY : Cloud Computing - Pharmacovigilance TRIAL DESIGN : Placebo Effect of Transdermal NSAIDs SITES : IRB Registration SUBJECT RECRUITMENT : Formula for Recruitment Success Also in this issue : e-Submissions Gain Support, Personalized Medicine, iPad Apps for Clinical Trials, R&D Productivity
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Articles in this issue
over 15 years ago
Patient Recruitment Feasibilityover 15 years ago
Archiving Approach in the UKover 15 years ago
Taking Clinical Computing in Handover 15 years ago
Business and News Update June 2011over 15 years ago
Getting Personal Over Personalized Medicineover 15 years ago
Early Use of Antiretrovirals May Reduce HIV Transmissionover 15 years ago
Moffitt Cancer Center Chooses Oracleover 15 years ago
Current Challenges of Poor R&Dover 15 years ago
Placebo Effect of Transdermal NSAIDSover 15 years ago
Language & Culture in Global Clinical TrialsAdvertisement
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.
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