December 29, 2025
Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data
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Journal Articles
March 18, 2025
Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model?
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March 16, 2025
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation—A TransCelerate Perspective
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September 6, 2024
Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment
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December 17, 2023
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment (Therapeutic Innovation & Regulatory Science)
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December 1, 2023
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8 (Therapeutic Innovation & Regulatory Science)
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October 4, 2023
Call to Action: Harmonisation of Pharmacovigilance Regulations for Post-marketing Pregnancy and Breastfeeding Safety Studies (British Journal of Pharmacology)
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June 21, 2023
Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines-Agree or Disagree? That is the Question (Therapeutic Innovation & Regulatory Science)
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June 3, 2023
Negotiating your way through the vigilance agreement maze-is there an easier way? (Therapeutic Innovation & Regulatory Science)
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June 2, 2023
A quality management system aiming to ensure regulatory-grade data quality in a glaucoma registry (PLOS ONE)
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