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Ensuring Flexibility when Approaching CTIS   

When Catalyst Oncology implements the European Union Clinical Trial Regulation (EU CTR) across Sponsor studies the Site Activation Management (SAM) team is often ask...
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Pulse Oximeters and Addressing the Potential for Bias  

As a result of the coronavirus disease 2019 (COVID-19) public health emergency, pulse oximeter usage has increased in both hospital and home settings. The US Food an...
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Rethinking Big Data Will Lead to New Advances in Personalised Medicine  

The life sciences industry has waited a long time for big data to transform the potential of personalised medicine. With AI and machine learning now coming of age, R...
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Changing the Narrative of First in Human Oral Drug Development: The SMART Advantage  

In the intricate realm of pharmaceutical development, First Human Dose (FHD) studies represent a pivotal juncture, replete with complexities yet essential for advanc...
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Reviewing Research Participant Payments Through a Diversity Lens  

Whether and how a participant is compensated for taking part in a clinical study are two of the decisions an institutional review board (IRB) makes when approving re...
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Designing and Executing a Robust Feasibility in Rare Disease Clinical trials  

Rare disease studies, especially those conducted in paediatric populations, present considerable challenges at a country, site and patient level due to their complex...
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Liver Disease, Obesity and the Value of Treatment  

Since 1990, the prevalence of obesity has more than doubled. In 2022, nearly one billion people were living with obesity. i The health risks of being obese or overwe...
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Could GenAI be Pharma’s Silver Bullet for Medical Writing? Only if Aimed Carefully  

As an acutely ambitious and overstretched Pharma industry increasingly identifies the vast potential of Generative AI to transform medical writing, across a range of...
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Using RBQM and New Technologies to Enhance Data Analysis and Enable Faster Review and Decision Making 

An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors want to be able to review data which has been analysed quickly a...
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Ensuring Integrity in Clinical Trials: The Role of Small-Box Technology   

Niall Balfour, Chief Executive Officer at Tower Cold Chain, explores the role of small box, temperature-controlled containers in the clinical trial market.  ...
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