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Therapeutic Innovation & Regulatory Science|May 28, 2021
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug DevelopmentTimothé Ménard, Alaina Barros, Christopher Ganter
Drug Safety|July 14, 2021
Bayesian Modeling for the Detection of Adverse Events Underreporting in Clinical TrialsYves Barmaz, Timothé Ménard
Therapeutic Innovation & Regulatory Science|March 9, 2022
Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote AuditingBjörn Koneswarakantha, Timothé Ménard
Pharmaceutical Medicine|August 26, 2021
Clinical Quality in Cancer Research: Strategy to Assess Data Integrity of Germline Variants Inferred from Tumor-Only Testing Sequencing DataTimothé Ménard, Donato Rolo, Björn Koneswarakantha
Drug Safety|May 25, 2019
Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine LearningTimothé Ménard, Yves Barmaz, Björn Koneswarakantha, et al.
Contemporary Clinical Trials Communications|October 19, 2020
Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study exampleTimothé Ménard, Rich Bowling, Pooja Mehta, et al.
Therapeutic Innovation & Regulatory Science|August 18, 2020
Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and PlanningMin Zou, Yves Barmaz, Melissa Preovolos, et al.
Therapeutic Innovation & Regulatory Science|September 1, 2020
Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?Björn Koneswarakantha, Timothé Ménard, Donato Rolo, et al.
CPT: Pharmacometrics & Systems Pharmacology|July 11, 2021
Cross-company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry groupTimothé Ménard, Kyle Young, Laura Siegel, et al.
Therapeutic Innovation & Regulatory Science|May 11, 2026
Critical to Quality Assessment Methodology: An Adaptable Clinical Trial Risk Management and Quality Assurance Approach for Quality Functions in Pharmaceutical Companies, Developed by the Inter-Company IMPALA ConsortiumKiernan Trevett, Jennifer Emerson, Paula Walker, et al.
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