Conducting clinical trials in Asia Pacific (APAC), United States and South Africa:

 APAC Region (include ANZ)

Our widespread and indigenous Grand Pacific APAC team understands:

• • • The different regulatory requirements and processes in different countries.
    • How to select local investigative sites that are familiar and capable of complying with ICH-GCP guidelines.
    • How to identify the standard of care, which varies between countries, impacts the recruitment rate and overall clinical trial timelines.
    • The ethnical, cultural, and linguistical diversity of the APAC region. Ethnic and cultural norms can influence perceptions of disease and attitudes towards clinical trial participation. In addition, this diversity can contribute to study complexity with the need to translate study materials and train site staff in multiple languages.

 The APAC region offers:

• • • Access to a large population of patients and treatment-naïve patients.
    • A cost-effective way for patients to get access to innovative treatments, as government healthcare budgets in APAC tend to be lower than those in North America and Europe.

Trials in Australia & New Zealand offer:

• • • • 43.5% “cash back” benefit now available for eligible foreign companies undertaking R&D in Australia.
      • Efficient regulatory environment (TGA)
      • Globally recognised standards.
      • Australian/New Zealand government incentives, benefits, investment and support.
      • Clinical trial aware and willing population.
      • Structured documentation process, e.g template Clinical Trial Research Agreements.

 The US offers:

• • • Experience in clinical trial execution as the highest percentage of clinical trials are conducted in the US.
    • Availability of thousands of qualified, inspected and verified investigators and sites.
    • A robust and easy regulatory system (FDA).
    • A professional clinical research culture.

 South Africa offers:

• • • Government support in improving population health especially in oncology, TB, HIV, diabetes, coronary diseases, and respiratory conditions.
    • Efficient clinical trial application and approval process.
    • Favourable exchange rate favouring sponsor budget.
    • Patient diversity and disease diversity support several types of research.
    • Fast patient recruitment as more than 70% of South Africans receive treatment at state institutions as opposed to private medical care. 
    • Many large oncology centres and established SMOs.