The role of IOR & EOR services is becoming crucial in optimizing clinical trials in Japan. Clinical trials are essential for the development of new drugs and medical devices. Japan, being a significant player in the pharmaceutical industry, has become an attractive location for conducting clinical trials. This is due to its diverse patient population, […]
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The regulatory and approval of drugs in Singapore is a rigorous and comprehensive process. This is to ensure the safety, quality, and efficacy of drugs sold in the country. Although the process may be complex and time-consuming, people generally consider it transparent, predictable, and science-based. The significant market for therapeutic products in Singapore is expected […]
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Aside from being one of the most preferred regions to conduct clinical trials, North America is also the location of 45% of global clinical trials, which is why researchers prefer this region. The increasing prevalence of cancer, heart disease, infectious diseases, and tropical diseases has generated multiple unmet requirements for the research of new drugs. […]
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In the pharmaceutical industry, regulatory affairs and translation are critical. Regulatory affairs encompass the procedures and actions to ensure compliance with safety, efficacy, and quality standards set forth by relevant authorities for pharmaceutical products. Translation, on the other hand, refers to the accurate translation of regulatory documents, product labels, and instructions, from one language to […]
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Accurate translation is essential for successful clinical trials. It ensures that participants understand the study procedures, risks, benefits, and potential adverse events. Inaccurate translation can lead to misunderstandings that impact the validity of study results. Accurate translation of study documents is crucial for consistency and minimizing errors during data collection and analysis. Regulatory non-compliance with […]
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Translation plays a crucial role in facilitating accurate communication between participants, researchers, and sponsors in conducting clinical trials on a global scale. This can be a challenging task, especially when language barriers come into play. Clinical trials are critical for developing new drugs, medical devices, and treatments. These trials aim to test the safety, efficacy, […]
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For medical device companies looking to enter the Singapore market, the registration process can be complex and time-consuming. However, it is a necessary step to ensure compliance with regulatory requirements and bring products to market. The medical device industry in Singapore has seen significant growth in recent years. The market is driven by a number […]
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The process of registering over-the-counter (OTC) medicines in Australia is regulated by the Therapeutic Goods Administration (TGA). The exact process depends on the type of product and the regulatory pathway but typically involves the submission of detailed documentation and scientific data to support the safety, quality, and efficacy of the product. What are OTC (over-the-counter) […]
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We use Standard Operating Procedures (SOPs) – uniformly written instructions with thorough explanations – to document common tasks, procedures, and organizational practices. SOPs in clinical research serve to define the group’s standard practices. They outline the daily research procedures to ensure that we adhere to institutional, state, and federal guidelines while conducting research tasks. We […]
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The registration of prescription medicine in Australia is straightforward, and the TGA evaluates applications for quality, safety, and efficacy. Australia ranks among the largest healthcare markets worldwide as its health system is one of the best in the world and provides quality, safe, and affordable healthcare for its citizens. The value of the Australian pharmaceutical […]
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