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Current Edition

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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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