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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Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.