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 […]
Read More →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 […]
Read More →Regulatory feasibility assessment is one of the most important and first steps in conducting a clinical trial. It helps evaluate the compatibility of a clinical trial design, adhere to current regulatory requirements and compliances, and focus on safety and efficiency to conduct a proper clinical trial. This phenomenon works as a bridge between regulatory requirements […]
Read More →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 […]
Read More →Global trials are critical for developing orphan drugs because they provide the necessary platform to evaluate the safety, efficacy, and overall impact of these therapies on rare disease populations worldwide. Orphan drugs are specifically designed to treat rare diseases and face unique challenges during development, particularly due to the limited number of patients available for […]
Read More →Thailand is rapidly emerging as a key player in the global clinical trial landscape, with the market expected to reach USD 3.5 billion by 2027. The country’s strategic location in Southeast Asia provides access to a diverse patient population, essential for robust clinical research. Moreover, Thailand’s healthcare system is well-equipped with state-of-the-art facilities and skilled […]
Read More →Regulatory oversight is crucial for ensuring the safety and efficacy of Software as a Medical Device (SaMD) solution. Understanding global regulations is essential for developers to navigate risk classification, quality management, post-market surveillance, and international standards, thereby ensuring compliance and fostering innovation in healthcare digitalization. SaMD presents a range of advantages that are reshaping the […]
Read More →Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]
Read More →Many regulatory agencies across the world are offering incentives for the development of orphan drugs for rare diseases. These incentives include financial benefits, faster approvals, less stringent clinical data requirements, and many more. The countries that are offering the regulatory incentives for orphan drugs include the US, Europe, Japan, Australia, South Korea, Brazil, and most […]
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