According to a recent analysis by an agency, the Malaysian pharmaceutical market is anticipated to increase from $2.3 billion in 2015 to $4.6 billion by 2022, reflecting a 9.5% CAGR. Seeing this demand many manufacturers are showing interest in registering their drug products in Malaysia. This information was last updated in March 2023. Factors such […]
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A clinical trial’s outcome depends on several variables, but one of the most important is patient recruitment. Ineffective trial recruitment strategies can cause late-stage trials to be delayed by roughly 11 months, increasing operational costs and extending time to market. Clinical trial recruiting strategies begin with the patient in mind and include a range of […]
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Clinical research is a field that can be difficult in and of itself. So it is essential to understand the knowledge and skill requirements for the various roles. A healthcare professional who oversees various duties for clinical trials and other kinds of medical research is a clinical research associate (CRA). A clinical research associate does […]
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Japan has the same regulations and practices for nutraceuticals, food, and beverage goods as any other nation. Legitimate safety regulations, regulatory protectionism, and customs taxes present manufacturers with significant obstacles when they attempt to enter the market. The Ministry of Health, Labour, and Welfare (MHLW) and Consumer Affairs Agency (CAA) are in charge of enforcing the Food […]
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Clinical Biostatistician and biostatistics are crucial for clinical trials and team members because they are path deciders for finding clinical trial end-points. For instance, it is essential to understand how to derive the components used in the analysis and assumption of the resulting data. The statistician’s role is critical from the start to ensure that […]
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While people often seek dietary supplements, many have concerns regarding their potential benefits, safety, and efficacy. As a result, clinically tested and approved food supplements have a strong market presence. It is important to conduct clinical trials on dietary supplements under Good Clinical Practice (GCP) guidelines to ascertain their potential benefits. Health and diet have […]
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The medical device market has grown significantly in recent years. Recent estimates suggest that the global market for medical devices will reach $612.7 billion by 2025. However, competition is fierce, and medical device companies of all sizes have questions about where and how to register their device. The information in this article was last updated […]
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Although many clinical trial sites wish to use technology, they are concerned about software compliance, particularly regarding 21 CFR Part 11 compliance. Using non-compliant technology can result in audits and tense interactions with the FDA and other regulatory authorities. In order to obtain smoother and quicker approvals from the regulatory authorities, researches need to use […]
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The concept of a “digital clinical trial” means leveraging digital technology to improve patient and sponsor experience in handling clinical trials using digital tools to manage end-to-end clinical trial solutions. Digital clinical trials also improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation and has the potential to transform clinical trials […]
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In recent years, hundreds of clinical trial investigations were performed using stem cell to treat common and life-threatening conditions such as heart disease, Alzheimer’s and diabetes. But till now, the only stem cell-based treatment routinely reviewed and approved by the U.S. FDA is hematopoietic (or blood) stem cell transplantation. The efficacy and safety of stem […]
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