Clinical Trials in Asia

To support clinical trials in Asia, CSOFT’s strategist group helps guide global companies by providing a thorough understanding of the pharmaceutical industry in China and partners with experts to help them effectively engage with the Chinese market.

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China is considered one of fastest-changing markets for global drug companies, making it a top consideration for clinical trials in Asia. As a result of changes in demographics, China’s regulatory and clinical landscapes have been undergoing fast and constant transformations.

China has an aging population, with 10 percent of its 1.38 billion citizens over 65.  Additionally, the Chinese population accounts for a considerable percentage of worldwide cases of diabetes, hepatitis B and C, and cancers. Considering these facts, the medical needs facing the country in order to receive adequate treatment positions China as a key strategic clinical trial market for global drug developers.

Clinical trials are proven to be efficient and important for discovering new treatments for a variety of diseases, as it helps reduce developing and redeveloping diseases. Foreign companies that are trying to conduct clinical trials in China are required to complete intensive paperwork and form partnerships with local Chinese companies. CSOFT’s strategist group guides global companies to provide a thorough understanding of the pharmaceutical industry in China and partners with experts to help them effectively engage with the Chinese market.

Conducting clinical trials in Asia
Consult National healthcare and regulatory reforms

Advise Local qualified partners for conducting clinical trials / CROs

Strategize Clinical trial plans

Design Clinical trial proposals

Support CTA applications and other regulatory compliance matters

Monitor Safety and efficacy through the full product life cycle from clinical studies to post-approval commercialization

Clinical Trials in Asia: Methodology

Research

    Data analytics & evaluation skills

    Product gap analysis

    Access to first-hand
    market data & intelligence

    Access to first-hand
    market data & intelligence

    Deliverables

    Market research reports

    Data summaries

    Proposals

    Comments & feedback

Clinical trials in Asia

Consulting

Medical market

Healthcare system

Pharmaceutical regulations

Latest updates and revisions to regulations

Cultural and linguistic differences

Communications

RA executives

International marketing and sales team

Key opinion leaders (KOLs)

Local experts in NMPA regulations and clinical trials in China market