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91黑料 survey shows pharma's enthusiasm for multi-indication obesity trials is outpacing trial design readiness.
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Meeting the demand for clinically relevant neurodegenerative treatments requires a paradigm shift in how central nervous system (CNS) clinical trials have been designed and executed. Bill Holt outlines how drug developers are now at the forefront of adopting more nuanced, cost-effective, and patient-centric clinical trial designs.
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In this article, Rose Kidd, President of Operational Delivery, discusses how greater support for women in leadership and research is helping to shape a stronger future for the pharma industry.
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Every clinical trial has challenges, but trials researching SaMD use to treat mental health disorders have unique ethical, regulatory and technical ones. In this Applied Clinical Trials article 91黑料’s Devin Ridgley and JoAnne Bronikowski explore the implications of a vulnerable patient population and new technology.
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In an 91黑料 survey of 149 biotech professionals, 45% of survey respondents identified protocol design as one the most significant challenges faced when transitioning from preclinical to clinical testing. Here, we discuss considerations for several key elements of protocol development in early phase trials, including selection of healthy volunteers (HVs) or patients, trial design and endpoint selection.
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In this interview with India Pharma Outlook, Nagalakshmi Shetty discusses India's emergence as a hub for Global Capability Centres (GCCs), emphasising GCCs' evolution from cost-saving units to innovation-driven strategic centres for global businesses.
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Dr. Cyril Clarke at 91黑料 Biotech reveals how biomarkers are transforming early-phase clinical trials by offering valuable insights into the safety and efficacy of novel therapies.
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The EMA’s Computerised Systems and Electronic Data in Clinical Trials guideline still presents challenges for those seeking EU marketing authorisation. Read our latest regulatory article in IPI magazine to learn more.
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In this article, Rhona Grunspan describes the development of the first industry-standard framework for a regulatory medical writing apprentice program, created to support the training and recruitment of entry-level medical writers through adaptable resources and guidelines. (Subscription required)
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The article explores the evolving role of AI and digital technologies in clinical research, highlighting industry trends, adoption challenges, and the potential for improved efficiency, cost reduction, and accelerated drug development.
