Applied Clinical Trials Direct
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  May 30, 2013
In This Edition
News Roundup: Streamlining IRB Documentation Processes
Articles: Negotiating Clinical Trial Agreements and Budgets
Blog Posts: Phase II/III Outsourcing Growth
Marketplace: Marketplace


News Roundup
bullet CTMS Streamlines Managing IRB Documentation
bullet Web Portal Survey: Access Studies Progress Through Single Portal
bullet CEL-SCI Expands Phase III Trial
bullet PharmaSeek Implements Allegro CTMS for Site Management


Articles
bullet GSK Vaccines Complements RBM with Intelligent Statistical Modeling Solution
bullet Negotiating Clinical Trial Agreements and Budgets with Sites


Blogs Posts
bullet Phase II/III Outsourcing Growth
bullet Europe Faces Gaps in International GCP Inspections

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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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Lisa Henderson
Editor in Chief
[email protected]