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In this ISSUE

Getting the "Right" Patient Input to Decision-Making

Rare Disease Research: It Pays to Engage

Centralizing Your Clinical Trials Office

Risked Based Monitoring
Tech Implications for New ICH Addendum
Sponsors and CROs can integrate existing and emerging technologies while transforming their reactive oversight strategies to an RBM approach using these steps.
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Click here and press play in our video player to watch a short video about Covance's Xcellerate Monitoring solution, to help you prioritize patient safety and data quality, support protocol compliance, and optimize resource utilization.
Precision Medicine
Parkinson's Patient Benefit-Risk Preference in Trial Design
A new group of collaborators has formed to determine the benefits and risk tradeoffs Parkinson's disease patients are willing to make for a potential new therapy.
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Podcast: E-Signatures and Digital Workflows in Clinical Trials
In clinical trials, the use of eSignatures to improve document workflows such as protocols, informed consent, and investigator brochures, has increased. All documents that need signed approvals eSignatures can be implemented to streamline, improve and make the transferring of those documents more efficient. This podcast discusses areas in clinical trials where eSignatures and document workflow can be applied for upstream benefits. Click here to listen
Protocol Design
Centralized Monitoring for Improving Investigational Sites and Oversight Performance
Centralized monitoring is a suitable way in which sites can identify and control investigational risks while improving performance.
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Pediatric Oncology Trials: Changes on the Horizon
Live Webinar: Tuesday, December 13 at 2:00 pm EST
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Executive Profile
Abbvie's Susan Callery-D'Amico on TransCelerate's QMS Initiative
Abbvie's Susan Callery-D'Amico speaks to us about TransCelerate's QMS Initiative and Issue Management.
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00 am EST
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Opinion
Why Pharma Should Be Looking to Aerospace
The pharma and aerospace industries share similarities whereas both are highly regulated, risk adverse and fast-paced markets.
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The Next Wave of Centralized Monitoring
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Calendar
/ Cannabis-Based Therapies 11/30-12/1 /
San Francisco, California
/ Clinical Trial Agreements, Investigator Payments and FMV 12/6-12/7 /
Philadelphia, Pennsylvania
/ Clinical Data Disclosure and Transparency 1/25-1/26 /
Philadelphia, Pennsylvania
 
 
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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
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Ask the editor
Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com
 
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Simplifying the complexities of global rare disease drug development
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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com
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