Applied Clinical Trials Direct
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  August 6, 2013
In This Edition
News Roundup: INC Research Opens Two New Offices in Asia/Pac
Blog Posts: Are Regulators Using RBM Tools?
Marketplace: Marketplace


News Roundup
bullet INC Research Opens Two New Offices in Japan
bullet Initiative Addresses Streamlining Researchers Qualifications
bullet PSI Expands to South Africa
bullet MedTrials’ Chooses Solution for Clinical Trial Documentation

Blogs Posts
bullet Are Regulators Using RBM Tools?
bullet Is PRO Data Being Used in Health Technology Assessments?


Sponsored
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

Events
bullet Risk-Based Monitoring Conference: Read the Brochure
bullet New Ways to Patient Engagement

Marketplace

Sponsored
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

Sponsored
LabCorp
Register now! Complimentary webinar! “Endocrine Testing: Case Studies & Solutions for Clinical Trials” broadcast live August 7 (North America) & August 8 (Asia and Europe).


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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Lisa Henderson
Editor in Chief
lhenderson@advanstar.com