Site engagement plays a key role in the success of clinical trials. Starting engagement at the right time and managing it well can make the trial process easier and more efficient. Using engagement strategies from the planning stage to post-trial collaboration helps overcome challenges like patient recruitment, ensures compliance, and improves data quality. This approach […]
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Successful clinical trials are undoubtedly the result of a well-implemented Quality Management System (QMS), and integrating Quality by Design in clinical trials ensures that this system goes beyond merely fulfilling regulatory requirements. Incorporating a proactive approach like Quality by Design (QbD) while configuring a QMS structure for clinical trials raises the probability of risk management […]
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Oncology clinical trials play a crucial role in addressing the current global cancer crisis, which affects millions of people worldwide. According to the World Health Organization and other research bodies, cancer remains one of the leading causes of death globally. Efforts to combat this disease involve a combination of prevention, early detection, and advanced treatment […]
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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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In clinical trials, patient engagement has a direct impact on retention, which affects how well medical research turns out overall. Keeping patients in the study is key to making sure the trial results are valid and reliable. When people stick with the study, researchers can gather complete data and get accurate results. However many trials […]
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