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Therapeutic Innovation & Regulatory Science|September 1, 2020
Technology Considerations for Enabling eSource in Clinical Research: Industry PerspectiveDonald G Jennings, Amy Nordo, Aruna Vattikola, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Quantitative Safety Monitoring in Clinical Trials: Application of Multiple Statistical Methodologies for Infrequent EventsJiabu Ye, Shihua Wen, John Schoenfelder, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in JapanEiji Kajiwara, Haruki Kamizato, Mayumi ShikanoTherapeutic Innovation & Regulatory Science|September 1, 2020
Correction to: How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural EnhancementThomas Severin, Solange Corriol-Rohou, Christina Bucci-Rechtweg, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic CrisisWeichung J Shih, Chen Yao, Tai XieTherapeutic Innovation & Regulatory Science|February 3, 2020
Lessons Learned From Multi-regional Trials With Signals of Treatment Effect HeterogeneityGang Li, Hui Quan, Gordon Lan, et al.Therapeutic Innovation & Regulatory Science|February 3, 2020
Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and DevelopmentStella Stergiopoulos, Debra L Michaels, Barbara Lopez Kunz, et al.Therapeutic Innovation & Regulatory Science|February 3, 2020
Tenders for the Procurement of Medical Devices: Adapting Cost-Effectiveness Rules to the Requirements of the European Public Procurement DirectiveAndrea Messori, Sabrina Trippoli, Erminia Caccese, et al.Therapeutic Innovation & Regulatory Science|February 3, 2020
Statistical Methods for Clinical Study Site SelectionJianjin Xu, Lan Huang, Zhihao Yao, et al.Therapeutic Innovation & Regulatory Science|February 3, 2020
Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III TrialsDaphne Guinn, Erin E Wilhelm, Ira ShoulsonPageof 165