The Indian healthcare system has been traditionally plagued by challenges such as inadequate infrastructure, limited access to quality care, and a shortage of skilled professionals, is witnessing a paradigm shift with the advent of Generative Artificial Intelligence (GenAI). GenAI is an AI subset dedicated to the creation of new content by learning patterns from existing […]
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clinical trial simulation Artificial Intelligence (AI) entails the use of computer techniques that make it possible for machines to undertake activities such as perception, reasoning, learning, and decision-making. New AI forms are being developed owing to progress in technology which has fueled developments in sectors such as facial recognition, finance strategy, autonomous cars etc. The
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The world of regulatory submissions is transforming where static documents and data tables are slowly giving way to a more dynamic approach – interactive safety graphics. Traditional methods of presenting this data have evolved significantly with the advent of interactive safety graphics. These dynamic tools are transforming the way submission content is reviewed, how clinical study reports
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The need for effective clinical trial dialogue is imperative to ensure clarity, consistency, and alignment with stakeholders. A comprehensive framework for effective clinical trial not only facilitates this but also helps in enhancing trial outcomes and decision-making. An estimand may be used when conducting health-related studies or interventions to help clarify how to interpret treatment
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Accelerating Clinical Trials in the European Union (ACT EU) is an ambitious initiative to revolutionize clinical trials across Europe. This initiative brings together regulatory reforms, technological advancements, and collaborative processes to create a more efficient and impactful environment for clinical research. The ACT EU objective is to enable smarter clinical trials, through regulatory, technological and
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The development of new drugs is a complex process involving clinical trials conducted across multiple countries. This can lead to challenges due to differing regulatory requirements and variations in how clinical trial protocols are formatted. The International Council for Harmonization (ICH) M11 Protocol Template, based on the ICH M11 guideline, aims to address this by
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Drug safety in clinical trials is ensured through the application of statistical approaches. Adequate planning for safety analyses helps in identifying potential adverse events, evaluating their impact and ensuring that the benefits of a drug are greater than the risks associated with it. It starts from early stages i.e., with the designing of clinical trials
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Medical research is progressing rapidly to keep up with the increase in complex disease. This has highlighted the need for innovation in clinical trials that can be driven by enhanced communication and collaboration. Stakeholders such as clinicians, researchers, patients, etc. can accelerate the development of novel therapies in order to improve patient outcomes by enabling
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The pharmaceutical industry is evolving with technological advancements with a subsequent increase in regulatory scrutiny that emphasizes maintaining the accuracy, completeness, and reliability of data- it has become more critical than ever. Data integrity ensures that information is trustworthy, verifiable, and compliant with regulatory standards. It is essential for safeguarding patient well-being, supporting regulatory approvals,
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Regulatory agencies like the United States’ FDA are increasingly encouraging electronic submission of Investigational New Drug (IND) safety reports. Electronic submission has numerous advantages over traditional paper-based submissions such as efficiency, accuracy, accessibility, timeliness and standardization. IND clinical trial sponsors are required to submit the IND safety report of serious and unexpected suspected adverse reactions
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