Clarify the global objective
We separate US IND, MRCT, licensing, financing, and diligence needs because each requires different evidence and messaging.
Service 03
China-to-Global Strategy
For Chinese oncology innovators planning global development, we connect local evidence, global competition, regulatory questions, and executable site pathways into a clearer development strategy.
Service detail
Problem addressed
China-to-global development is not simply moving a trial overseas. Sponsors need to know which evidence will travel, which design decisions may be questioned, and which country and site pathways are more credible for later regulatory, enrollment, and partnering conversations.
What we analyze
- Connection between China evidence and global development questions
- Comparable US, Europe, APAC, and global trial pathways
- MRCT, bridging, single-region concentration, and representativeness considerations
- Question types that may need preparation before FDA-facing discussions
- Global competitor context, differentiation pressure, and partnering implications
- Country, region, and site profiles that merit first-wave diligence
What clients receive
- China-to-global development pathway memo
- Country mix and candidate site profile recommendations
- Evidence gap, regulatory question, and readiness checklist
- Leadership, investor, or BD discussion deck
- Questions to align with CROs, regulatory advisors, or external experts
How the work moves forward
Planning a China-to-global oncology path?
Start with non-confidential background on mechanism, stage, existing evidence, and target regions. We can scope the next analysis from there.
Build the pathway view
We evaluate competitor context, countries, sites, evidence, and regulatory questions inside one development path.
Define next actions
We identify what to prepare first, which assumptions require validation, and which paths should not enter the first-wave plan yet.