Overview
Conducting separate trials for every region is no longer feasible. We help you design Multi-Regional Clinical Trials (MRCTs) that satisfy the statistical and ethnic sensitivity requirements of the FDA, EMA, PMDA, and NMPA simultaneously.
Key Features
Global protocol design
Statistical analysis planning for regions
Ethnic sensitivity assessment
Operational feasibility
Our Process
1
Design
Creating a protocol that meets all regional guidelines.
2
Validation
Confirming acceptance with health authorities.
3
Oversight
Ensuring consistent execution across all sites.
Project Complete & Deliverables Provided
Frequently Asked Questions
ICH E17 (General Principles for Planning and Design of Multi-Regional Clinical Trials) was finalized in 2017 to facilitate simultaneous global drug development. It provides a framework for designing pivotal trials that satisfy multiple regulatory agencies—FDA, EMA, PMDA, NMPA—with a single protocol. The goal is reducing duplicative regional studies and accelerating global patient access.
Why Choose Us
- Reduced total development cost
- Simultaneous global submissions
- Faster patient recruitment
- Consistent safety profile
Get More Details
Request a personalized consultation and detailed information about this service.
Personalized consultation
Detailed service information
Custom timeline & proposal
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for Multi-Regional Clinical Trials.
Schedule ConsultationWhat Our Clients Say
"Designing an MRCT that satisfied FDA, EMA, PMDA, and NMPA seemed impossible. Adelphi facilitated parallel scientific advice meetings with all four agencies and helped us find a design everyone could accept. Our pivotal trial supported simultaneous global submissions."
Dr. Sarah Chen
Head of Global Clinical Development
Global Biotech
Related Services
Explore other ways we can support your regulatory needs