From molecule to market – IQVIA’s end-to-end support in JAPAN
IQVIA Japan capability
Pre-IND
Phase I
Phase II / III
Product Launch
Commercialization
& Lifecycle Management
*1 In Japan CTN (Clinical Trial Notification) application is required.
Pre-IND
IND Submission
First in Human Proof of Principle
Study Initiated
Interim Analysis
In-house Database Lock
Results
Study
Initiated
In-house Database Lock
Commercialization
Decision
Completion
File NDA
Rare Disease Designation
Managed Care Agreements and/or PricingAnnounced
FDA or
Regulatory Approval
Guideline Adoption
Ongoing Growth
and Lifecycle Management
Seamless single arm trial design
Phase III
Phase II
*1
*1
Pre-IND
IND Submission
First in Human Proof of Principle
Rare Disease Designation
Study Initiated
Interim Analysis
In-house Database Lock
Results
Study
Initiated
In-house Database Lock
Commercialization
Decision
Completion
File NDA
Managed Care Agreements and/or PricingAnnounced
FDA or
Regulatory Approval
Guideline Adoption
Ongoing Growth
and Lifecycle Management
*1