In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patient cost barriers and site infrastructure challenges must be solved together to close the participation gap in community and rural clinical trials.
|Articles|October 22, 2020
Elsevier, Novartis Collaborate on Drug Development Safety Risk Tool
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Global life sciences information analytics provider Elsevier announced a collaboration with Novartis to develop a safety margin risk assessment prediction tool, largely using Elsevier’s PharmaPendium data. The data, which includes searchable FDA and EMA drug approval documentation and packages (including Adverse Events Reports and FDA Advisory Committee meetings), and comparative drug safety, pharmacokinetic, efficacy, and metabolizing enzyme and transporter data, will be used to predict and better justify earlier in the process target selections for development related to human safety, interpretation of clinical significance, and early submission to monitor and mitigate safety risks throughout clinical drug development.
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