Key takeaways Asia-Pacific (APAC) has become one of the most attractive regions for clinical trials due to patient diversity, strong investigator networks, and lower operational costs. However, clinical trial start-up timelines remain highly fragmented across countries. Singapore remains the fastest and most predictable market for clinical trial activation due to centralized systems, parallel submissions, and […]

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Digital tracking devices play a pivotal role in modern clinical trials. They enable remote monitoring, enhance patient safety, and support continuous, real-time data capture. However, navigating Japan’s regulatory requirements for importing these devices can be complex and device-specific. Japan welcomes these advanced technologies, which are reshaping the design and execution of clinical trials. Therefore, it […]

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The Drugs Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO), overseeing DCGI approval in India, regulation, and quality standards of drugs and clinical trials. As the national regulatory authority, DCGI ensures patient safety and compliance with the Drugs and Cosmetics Act, 1940. DCGI in the Indian pharmaceutical and medical device […]

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