In today’s ACT Brief, we examine three priorities for first-time APAC sponsors, how continuous glucose monitoring should be used in diabetes trials, and why FDA is requiring a new eye-related warning across GLP-1 medications.
|Articles|August 1, 2010
- Applied Clinical Trials-08-01-2010
- Volume 0
- Issue 0
Applied Clinical Trials Digital Edition - August 2010
CRO/SPONSOR : The Nuances of Medical Device Trials A Triggered Approach to Site Monitoring INFORMATION TECHNOLOGY : Automating the Phase I Trial Also in this issue : FDA Addresses Concerns Over Foreign Studies, The Cost Factor in EU Drug Authorization, Baseball?s Ties to Comparative Effectiveness Research, Key Updates to the Form FDA 1572
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Articles in this issue
over 16 years ago
Applied Clinical Trials Digital Edition - August 2010, Supplementover 16 years ago
Business and News Update August 2010over 16 years ago
Automating Phase I Trialsover 16 years ago
Key Updates to the 1572over 16 years ago
Considerations for Medical Device Trialsover 16 years ago
Triggered Monitoringover 16 years ago
Foreign Clinical Trials Under Scrutinyover 16 years ago
Deconstructing Relative Effectiveness Effortsover 16 years ago
Diabetes Drug Updateover 16 years ago
Effective Comparisons: Baseball and CERAdvertisement
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In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, shares three priorities for first-time APAC sponsors: aligning with marketing authorization plans, selecting the right sites, and choosing a CRO with regional experience and KOL networks.
FDA and EMA expectations shape how sponsors use CGM in diabetes trials, from blinding and study-provisioned devices to data integrity and ePRO integration.
In today’s ACT Brief, we examine why APAC is attractive for global Phase III programs, how clinical research professionals can turn a failed pivotal trial into a redesigned success, and how FDA approved Sunharbo to reduce recurrent stroke risk.
A pivotal trial that missed its primary endpoint became the basis for a successful redesign after the team used the data to define the high-risk patients most likely to benefit, showing that setbacks can strengthen development when organizations interrogate the evidence rather than abandon it.
In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, outlines why faster recruitment, local data requirements for registration, and lower costs make APAC attractive for global Phase III programs.
In today’s ACT Brief, we examine how China’s trial startup timelines compare with those in the US and Europe, whether AI-drafted clinical study reports speed drug development, and how Bimzelx compared with Skyrizi in psoriatic arthritis.
AI can draft a CSR in minutes, but the report only reflects evidence that has already converged, so faster drafting shifts the bottleneck to upstream reconciliation, database-lock readiness, and human accountability rather than shortening the trial itself.
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