Embarking on Multiregional Clinical Trials (MRCT) demands careful consideration of various factors to ensure success. In this article, we will delve into five critical aspects of MRCT planning, covering everything from understanding MRCT models to practical strategies for global clinical trials. We'll explore the complexities of going global independently, licensing out, collaborating with multinational corporations, and discuss models like early-phase development and parallel development.

Understanding MRCT Models:

MRCT models vary based on company objectives and product stage. Chinese companies, for instance, often seek overseas connections around Phase II, synchronizing pre-IND and Phase III trials. Pharmacokinetic bridging studies may be necessary to address ethnic differences. Another model involves expanding a product from China to overseas markets, leveraging favorable policies for faster registration.

Planning for Global Clinical Trials:

Choosing between independent global expansion and licensing out requires a careful evaluation of funding, risk, return, and autonomy. Successful collaborations with multinational corporations, such as Legend Biotech and Johnson & Johnson, highlight the significance of clear terminology and strategic planning. Key considerations include market selection, regulatory compliance, and aligning trial designs with international requirements.

Early-Phase Development:

Early Clinical development involves strategic considerations for efficient the start of global expansion. Choosing the most optimal location for early-phase trials, such as Australia or China, depends on factors like regulatory efficiency and acceptance by the FDA. Real case studies, like Novotech's Regulatory Consulting project in Australia, demonstrate how global data can accelerate studies across all regions.

Pivotal Trials:

Pivotal trials present unique challenges, with country selection being a crucial first step. Factors like market potential, existing benchmark products, local data requirements, and medical practices impact country choices. A tiered classification system helps prioritize countries based on their suitability for the project. Tailoring strategies to meet company priorities ensures a focused and efficient approach.

Getting Things Ready:

The final section emphasizes the importance of executing study plans, patient recruitment, and effective collaboration. A well-defined Clinical Development Plan is crucial for guiding collaborators and aligning terminologies globally. Global patient recruitment involves engaging with local experts and Key Opinion Leaders. Crafting a detailed Request for Proposal early on streamlines the selection process for Clinical Research Organizations.

Overseas Collaboration:

The article concludes with practical tips for successful overseas collaboration, addressing challenges like the culture gap. Recommendations include establishing an overseas team, leveraging flexible resourcing models, and focusing on digitization and infrastructure development for smoother collaboration.


Planning and executing Multiregional Clinical Trials demand a comprehensive understanding of diverse models and careful consideration of regional nuances. By navigating these complexities with strategic foresight and adaptability, companies can optimize their global expansion efforts and contribute to the advancement of medical research on an international scale.

By: Dean Tang, Senior Director, Sales Operations & Corporate Strategy, China, Novotech


Media contact

데이빗 제임스 (David James)

언론 연락처

노보텍은 글로벌 실행 능력을 갖춘 아시아 태평양 중심의 선도적인 바이오텍 CRO 기업으로 국제적으로 인정받고 있습니다.

노보텍은 연구소, 임상1상 시험 기관, 약물 개발 컨설팅 서비스(DDC, Drug Development Consulting) 그리고 FDA 규제 전문성을 갖춘 임상 CRO 기업으로 1상에서부터 4상까지의 임상시험과 생물학적 동등성 시험을 포함하여 5,000건 이상의 임상 프로젝트에 참여한 경험이 있습니다.  노보텍은 아시아 태평양, 미국, 유럽에서 임상시험을 수행하고자 하는 바이오텍 고객들에게 서비스를 제공할 수 있습니다. 노보텍은 전 세계적으로 3,000명 이상의 직원과 34개의 사무실을 보유하고 있습니다.

보다 자세한 내용은를 통해 확인하실 수 있습니다.

기타 관련 콘텐츠