How to effectively incorporate PROMs in oncology trials
Clinical Trials Arena spoke to Anthony T. Everhart, MD, FACP; Clinical Vice President at leading evidence generation company, Signant Health,…
All articles by Hiriyti Bairu
Hiriyti Bairu
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Scale management: What do sponsors and CROs need to consider?
When it comes to implementing study-appropriate scales in clinical studies, sponsors often face challenges that can add unexpected time and…
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How electronic clinical outcome assessments improve clinical trial evidence generation
Ensuring clinical trial data is of high quality is critical; otherwise failure to do so could impact on endpoint reliability.…
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Serialization readiness: the path towards compliance
The Food Drug Administration (FDA) recently introduced a 12-month stabilization period, from November 2023 to November 2024, for the pharmaceutical…
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How serialization will shape the future of the pharma industry
Q: What are the key challenges facing the pharmaceutical industry when it comes to implementing serialization regulations?From a technological standpoint,…
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How CATs can enhance clinical trials
PROMs are composed of a fixed number of items – that is, a question and its associated response scale. While…
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New US serialization requirements: how will they impact the pharma supply chain?
First introduced in 2013 under The Drug Supply Chain Security Act (DSCSA), serialization aims to enable more effective traceability of…
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Harnessing decentralised methods for trial optimisation
Decentralising aspects of a clinical trial through enabling certain procedures and assessments to be conducted away from a site is…
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How pharma manufacturers can make their supply chains more resilient
With new pharmaceutical logistics providers emerging every day, it can be difficult for a manufacturer to determine which one will…