The success of any clinical trial hinges on meticulous planning, starting with the careful identification of red flags in site selection to effectively avoid pitfalls before the trial starts. A poorly selected site can lead to costly delays, data inaccuracies, and regulatory complications, ultimately jeopardizing the trial’s objectives. Addressing these challenges early in the process […]
Read More →Pharmacokinetics (PK) analysis and statistical methods are fundamental to the Bioavailability (BA) and Bioequivalence (BE) research process. PK analysis helps understand the drug’s absorption, distribution, metabolism, and excretion (ADME) in the body. At the same time, statistical methods assess whether the drug formulations under study are equivalent in terms of their therapeutic effects. Together, these […]
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 →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 →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 →The development of digital clinical trials has completely altered every aspect of our lives. One of the sectors with the most room for innovation is the health sector. However, the clinical research sector has been sluggish to accept digital clinical trials and integrate the digital tools that hold the secret to safer, more effective treatments […]
Read More →Over the past years, the number of conferences and publications devoted to decentralized and digital clinical trials has skyrocketed in the pharmaceutical research sector. Nearly every clinical research company has joined the conversation, fuelled by the global pandemic. Conferences are there almost weekly to discuss methods and equipment for transferring laboratory-based research to clinical settings. […]
Read More →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 […]
Read More →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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