Here you get all the information related to the clinical trials regulatory services, management, and clinical development.
The number of cell and gene therapies coming into the market each year is increasing steadily. An article published by McKinsey and Company in 2022 expected as many as 21 cell therapy and 31 gene therapy launches in 2024 itself. The growing focus on cell and gene therapies (CGT) presents a unique set of challenges to […]
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
Enhancing Global Drug Development through ICH M11 Read More »
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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Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options and therefore, have been a subject of considerable interest. Given the increase in
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Early-phase clinical trials for cell and gene therapy (CGT) products differ from those for other pharmaceuticals due to unique product features and previous clinical experiences, which have revealed substantial risks, including multi-organ failure, leukemia, and tumor development. Factors such as prolonged biological activity, immunogenicity, and invasive administration procedures contribute to these risks. The design of
Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products Read More »
