Clinical Trial Management in India can be exciting, but let us be honest, it is not always easy. Sponsors often run into situations where they need extra support for specific parts of a study, but do not want to hand over the whole project. Sometimes they are looking for local experts, other times they just […]

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Applying AI in clinical trials is no longer a futuristic concept; it’s a practical solution gaining traction across the industry. As clinical trials become increasingly complex—with growing data volumes, escalating costs, and stricter regulatory expectations—AI offers timely support. It is being used to optimize trial design, enhance site and patient selection, identify operational risks early, […]

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Bioavailability (BA) and Bioequivalence (BE) studies provide the evidence needed to prove consistency, efficacy, and product quality for the nutraceutical products. With the growing demand for science-backed nutraceuticals, demonstrating how well a product is absorbed and performs in the body is becoming essential. While these studies are well-established in pharmaceuticals, applying them to nutraceuticals presents […]

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Japan is quickly becoming one of the most important countries in Asia for clinical research, not just because of its strong healthcare system and regulatory structure, but also due to its growing focus on innovation and patient-centered studies. But running a successful trial in Japan takes more than just choosing a country; it requires selecting […]

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Running a clinical trial for rare diseases is very different from trials in more common conditions. Small patient numbers, limited data, and complicated rules make every part of the process more careful and more creative. Instead of going over the basics, this article focuses on advanced but practical things that experienced sponsors need to think […]

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Stepping into a first-in-human (FIH) clinical trial is a defining moment in drug development. It’s when a new drug that’s been years in the making finally transitions from lab bench to bedside. This isn’t about proving efficacy—that comes later. FIH clinical trials are all about safety, tolerability, and understanding how the drug behaves in the […]

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Pharmacokinetics (PK) analysis and statistical methods are fundamental to the Bioavailability (BA) and Bioequivalence (BE) research process. PK analysis helps understand the drug’s absorption, distribution, metabolism, and excretion (ADME) in the body. At the same time, statistical methods assess whether the drug formulations under study are equivalent in terms of their therapeutic effects. Together, these […]

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Selecting a site for clinical trials involves multiple considerations that impact the success of the research. The site choice plays a pivotal role in determining how effectively the trial is conducted, including patient recruitment, regulatory compliance, and data integrity. A well-chosen site can ensure smooth operations and contribute to the overall reliability of the results, […]

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When considering Vietnam for your clinical trials, several compelling reasons make it a top choice. Vietnam offers a unique combination of cost-efficiency, regulatory advancements, and access to diverse patient populations, positioning it as an attractive destination for pharmaceutical companies and researchers. As global interest in innovative drug development grows, many organizations turn to Vietnam for […]

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Japan has emerged as a premier destination for clinical trials, attracting global pharmaceutical companies and research organizations due to its advanced medical infrastructure, highly skilled workforce, and robust regulatory framework. With a rapidly aging population and a high prevalence of chronic diseases, Japan offers a unique environment for conducting clinical research. The country’s strict compliance […]

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