Consultation
- At strategic level for customers’ Clinical Development Plan and registration strategy, such as consultation in therapeutic indication(s), product profile, competing products, justification for development, clinical trials design and size, drug supplies, and resource planning
- Protocol design and development with scientific rigor, and based on deep knowledge of best practice and executional experience
- Consultation on execution planning, project key milestones, regulatory requirements compliance to support efficient and effective clinical research stage planning and execution
- Access to global experts and scientific advisory board for scientific inputs
- Quality oversight and support to identify potential issues, opportunities, and contribute to issue resolution
- Vendor assessment and due diligence services for sound decision
- A group of professionals with over an average of 20 years experience in global innovative drug development with broad spectrum of expertise, such as development strategies, clinical science, portfolio management, biometrics specialization, quality and compliance. Experience including regional and local clinical development site establishment, FDA new drug R&D administration, NMPA review expert, regulatory strategy, IPO roadshow, due diligence, leadership in industry associations, academic contribution and joint program set up with world-class universities, plus a variety of clinical development leadership programs and roles.
- R&D core member of RDPAC
- Advisory Board Member of DIA in China
- Adjunct Professor of leading University
Our Services:
Our Experience and Capabilities:
Certification and Professional Association Membership:
China：
298 Xiangke Road, 3/F, 301-305, Zhangjiang Hi-Tech Park, Pudong, Shanghai 201210, China
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515
US：
261 Madison Avenue, 24th fl. New York, NY 10016 US
Phone: +1-212-681-2100
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