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|April 1, 2010
- Applied Clinical Trials-04-01-2010
- Volume 0
- Issue 0
Applied Clinical Trials Digital Edition - April 2010
eCLINICAL : Global Advantages with CTMS From EDC to ETMS The Upfront Cost Hurdle of EDC eDiaries: Earlier is Better SUBJECT RECRUITMENT : Recruitment Grows on the Internet Also in this issue : FDA Wants Better Science, Flawed EU Directive, BRIDG for Better Models, NICE Gets Bad Rap
Advertisement
Articles in this issue
over 16 years ago
Alzheimer's by Phaseover 16 years ago
The Deeper Data Debateover 16 years ago
The Upfront Cost Hurdle of EDCover 16 years ago
Regulatory Science to Inform Trial Designover 16 years ago
Data Integration in the Age of Global Trialsover 16 years ago
Memories and Musings About Modelsover 16 years ago
Internet Recruitmentover 16 years ago
The Next Step for EDCover 16 years ago
Increasing Study Sensitivity in Early Trialsover 16 years ago
The EU Directive Really Doesn't Work!Advertisement
Related to this article
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.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Continuous Glucose Monitoring in Diabetes Clinical Trials: Endpoints, Regulatory Guidance, and Operational Best Practices
2
The Role of Clinical Research Professionals: From Early Discovery to Phase III Success
3
What Smaller Biotechs Need to Get Right in Their First APAC Phase III Trial
4
AI Can Draft the CSR Faster, But Does That Make Drug Development Faster?
5