Applied Clinical Trials Direct
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  June 11, 2013
In This Edition
News Roundup: CROs Take Longer for Study Start-Up
Blog Posts: Europeans Examine Clinical Trial Policy
Marketplace: Marketplace

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Improving Clinical Operations with Digital Signatures
On Demand Webcast
Register Free at: www.appliedclinicaltrialsonline.com/digitalsignatures

News Roundup
bullet Report Says CROs Slower at Study Start-Up
bullet TransCelerate Releases Position Paper on Risk-Based Monitoring
bullet PIs Take Lead in FDA-Regulated Studies
bullet European Think Tank Reports on Clinical Research Accreditation
bullet PRA Opens Site in Wales


Blogs Posts
bullet Last Chance to Vote!
bullet European Politics and Clinical Trials Policy


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How Innovative Outsourcers Are Succeeding at Virtual Trial Management
On Demand Webcast
Register Free at: www.appliedclinicaltrialsonline.com/innovative


Events
bullet CBI’s 5th Forum on Clinical Trial Budgeting and Project Management
bullet Clinical Patient Engagement Summit
bullet Risk-Based Monitoring

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Real-World Genetic Disease Research: Benefits of a Patient-Centric Research Platform
Live Webcast: Wednesday, June 19, 2013 at 11:00 am EDT
Register Free at: www.appliedclinicaltrialsonline.com/benefits

Marketplace

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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. Learn More



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Capsugel
DBcaps® capsules are uniquely designed for double-blind clinical trials. They can improve patient compliance, as well as reduce bias, when used in clinical trials to over-encapsulate comparator products. www.capsugel.com



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Bioclinica
BioClinica is Making DIA 2013 Fun with  myDIAfun.com! Places to eat, sights to see, cool booth promotions, and DIA networking events and parties.

Sponsored
Parallel Drug Development Strategies in China
Faster approvals, faster to market, and faster to patients worldwide. Learn More



Sponsored
New Strategies to Expedite Go/No Go Decisions in Oncology Trials
Live Webcast: Thursday, 13 June 2013 at 11:00 am EDT
Register Free at: www.appliedclinicaltrialsonline.com/oncologytrials


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. http://bit.ly/1azCfRJ


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Ask The Editor

Lisa Henderson
Editor in Chief
lhenderson@advanstar.com