Applied Clinical Trials Direct
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  July 25, 2013
In This Edition
News Roundup: Operational Change and RBM
Articles: Risk Based Monitoring: A Primer for Small to Mid-Size Sponsors
Blog Posts: Targeted Site Monitoring Trend
Marketplace: Marketplace

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Real-World Genetic Disease Research: Benefits of a Patient-Centric Research Platform
On Demand Webcast
Register Free at: www.appliedclinicaltrialsonline.com/benefits

News Roundup
bullet Operational Change and RBM
bullet The Role of Biostatistics in Clinical Trials (podcast)
bullet The Qs of Risk-Based Monitoring
bullet What Does RBM Mean to Sanofi’s CRAs and Site Monitors?


Articles
bullet Risk Based Monitoring: A Primer for Small to Mid-Size Sponsors
bullet Under-Utilized Data Becomes RBM Solution

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Update in Sleep Medicine: Impact of Nonrestorative Sleep for Mental Health Definition, Diagnosis, Evaluation, Treatment and Clinical Trials
On Demand Webcast
Register Free at: www.appliedclinicaltrialsonline.com/impact

Blogs Posts
bullet Risk-Based Approach to Monitoring
bullet Targeted Site Monitoring Trend

Events
bullet Meet Your Peers on Risk-Based Monitoring

Marketplace

Sponsored
Medidata
July 30 Webinar: "Using the Medidata Clinical Cloud™ to Implement TransCelerate’s Risk-Based Monitoring Methodology" - QdB, Risk, Critical Processes & Data, Indicators & Thresholds, Adaptive Monitoring.. [Register]

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Corporate Translations
The preferred supplier of translations to the life science industry. www.corptransinc.com



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Drug Development Strategies in China
Pharma and biotech firms who are relative newcomers to the Chinese market aren't aware that the regulatory climate has changed dramatically in recent years. SFDA approval times for Clinical Trials Approvals have dropped to 7-9 months for small molecules. There are also opportunities in China for sponsors that have not yet completed Phase II trials to create a parallel approval strategy. Even without final details (like final dosing) it’s possible to file a CTA for Phase III based on the most current early phase results. This parallel submission strategy can shave several months off the final approval time in China.
Read More

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Covance(Xcellerate)
A lot of CROs offer databases. But only Covance offers Xcellerate®, a more strategic approach to Clinical Trial Optimization ®. Learn more.



CHINA REPORT
China is the third largest pharmaceutical market in the world and will become the second largest ahead of Japan by 2015. Everything you need to know to do business in the country; key economic sector data and exclusive interviews from regional leaders. Read More

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Ask The Editor

Lisa Henderson
Editor in Chief
lhenderson@advanstar.com


Risk-Based Monitoring

Risk-Based Monitoring Conference SPOTLIGHT EVENT
Risk-Based Monitoring in Clinical Studies
Oct. 24-25, 2013
Philadelphia, PA

Download Brochure
Register

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- Risk-Based Approach to Monitoring
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