Search CHA
Drug Safety Executive Council
Home
About Collaborative Projects
Current Collaborative Projects - Enrollment Open
Leveraging Biomarker & Translational Research in China
Project Stages
About Collaborative Projects
Current Collaborative Projects - Enrollment Open
Evaluating Preclinical Cardio-Toxicity Assessment Tools
Leveraging Biomarker & Translational Research in China
Assessing GLP Compliance and Quality Practices in China
Exploiting Legacy Safety Studies
Assessing the Asian Supply Chain of Non-Human Primates (NHPs)
Case Studies of Past CHA Projects
Project Stages
STAGE I: Scope Translational Medicine & Biomarker Research Processes & Capabilities
Establish consensus among clients for specific research direction of project, including emphasis on technology platform, clinical center, and regulatory issues.
Timing: April-May 2007
STAGE II: Map of China-based Resources & Capabilities, and Review of Regulatory Framework
Formal project launches with circulation of a final biomarker and translational research service provider survey. Client-only, peer-to-peer roundtable (conducted via web conference) scheduled to discuss specific survey issues and build consensus on final questions to be included in survey. Follow-up one-on-one teleconference between each client and CHA project team as appropriate. Conduct comprehensive map of China-based translational medicine and biomarker providers (~60 sites). Also conduct review of regulatory framework for the collection, use, and export of human biological samples.
Timing: May-July 2007
STAGE III: Opportunity Identification & Site Selection
Review project findings to date, and re-prioritize as necessary to enable further in-depth research into specific areas of greatest interest to clients, including more focused due diligence on a subset of service providers (~40 sites) as well as follow-up on specific regulatory issues.
Timing: July-August 2007.
STAGE IV: CHA-led visits of clients to leading China-based biomarker & translational research service providers & regulatory authorities
CHA organizes, leads, and facilitates group visits by project clients to leading China-based biomarker and translational research service providers (~10 sites) as well as scheduled meetings with Chinese regulatory authorities/
Timing: September 2007
STAGE V: Findings Report, Presentation & Third Peer-to-Peer Roundtable
CHA presents a summary of findings and facilitates a peer-to-peer discussion of resulting implications and opportunities (via web conference).
Timing: October 2007
Download full Project Description
Contact Us
Previous Page
Back to Project Description
Next Page