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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Journal Articles
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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June 1, 2023
Digital Data Flow (DDF) and Technological Solution Providers (PharmaSUG)
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May 9, 2023
Decentralized study of COVID Vaccine Antibody Response (STOPCoV): Results of a participant satisfaction survey (PLOS Digital Health)
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April 5, 2023
Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations (Advances in Therapy)
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April 5, 2023
Development of a risk-tailored approach and dashboard for efficient management and monitoring of investigator-initiated trials (BMC Medical Research Methodology)
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March 27, 2023
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters (Therapeutic Innovation & Regulatory Science)
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March 7, 2023
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources (Journal of Biopharmaceutical Statistics)
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January 20, 2023
Pharmacovigilance Agreement Optimization (PVAO): Tools to Create a Customized PVA (Therapeutic Advances in Drug Safety)
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