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 […]
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 →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 […]
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 →Bioavailability (BA) and bioequivalence (BE) studies in India are crucial in drug development and regulatory approval processes. These studies ensure that generic drugs are therapeutically equivalent to their branded counterparts and that new formulations perform adequately. The importance of BA/BE studies has grown significantly in India, driven by the burgeoning pharmaceutical industry and stringent regulatory […]
Read More →Effective regulatory management is essential for the smooth advancement of the pharmaceutical product life cycle. It focuses on several specific regulations that govern different aspects of the product’s lifecycle. Regulatory compliance for products approved across multiple countries is a significant undertaking. Pharmaceutical product life cycle management is often fraught with challenges that can impede progress […]
Read More →Software as a Medical Device (SaMD) plays a pivotal role in healthcare worldwide, with its significance particularly pronounced in the United States. In an era increasingly reliant on digital solutions, SaMD offers innovative ways to diagnose, treat, and monitor health conditions, revolutionizing patient care. The United States, being a global leader in technology and healthcare, […]
Read More →Electronic data capture (EDC) has revolutionized the management of clinical trials, offering significant impacts and advantages over traditional paper-based methods. In clinical trials, precise and efficient data collection is crucial for ensuring the integrity and accuracy of research findings. EDC systems streamline this process by allowing researchers to enter data directly into digital platforms. The […]
Read More →The drug registration process in India involves rigorous evaluation by the Central Drugs Standard Control Organization (CDSCO) to ensure safety, efficacy, and quality before granting approval for marketing and distribution. The pharmaceutical industry in India is a dynamic and rapidly growing sector, offering significant opportunities for drug manufacturers worldwide. With a large population and increasing […]
Read More →Pharmaceutical research and development in the Asia-Pacific (APAC) region now heavily relies on clinical trial sourcing. Collaborating with research institutions and healthcare organizations fosters international research partnerships and facilitates knowledge exchange. Most countries in the Asia-Pacific region tend to seek this help because it brings several benefits. The success of clinical trials depends on the […]
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