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 →Project management in clinical trials involves the systematic planning, execution, and oversight of clinical studies to ensure their success. From initial planning stages to final execution and reporting, understanding the complexities and best practices of project management is crucial for achieving reliable and impactful results in clinical research. As clinical trials are essential for advancing […]
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 →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. […]
Read More →The number of clinical trials in rare diseases is growing drastically from the last ten years to more than 500 compared to a few hundred clinical trials. Currently, more than 400 orphan designated drugs are commercially available, and around 1000 drugs are undergoing clinical trials. But still, the clinical trials in rare diseases present many […]
Read More →For the approximately 7,000 known rare diseases, less than 10% of diseases have an FDA-approved treatment available. Due to a small number of patients, limited understanding of the variability and progression of the diseases, developing a drug or treatment for rare diseases is often challenging. As the disease is rare, finding sites to conduct clinical […]
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 […]
Read More →Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to regulatory compliance, temperature control (or, excursions), labeling, actual shipment, or last-mile delivery. These challenges are often compounded multi-fold when clinical trials are related to a […]
Read More →