Publications by authors named "Timothe Menard"

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Clearing the Mist: The Distinct Roles of Transparency and Explainability for Using AI in Drug and Device Development.
Timothé Ménard, Katrina A Bramstedt

Pharmaceut Med· November 2025

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Breaching Confidentiality in Genetic and Non-Genetic Cases: Two Problematic Distinctions - When the Law Comes to the Rescue.
Timothé Ménard

Am J Bioeth· October 2025

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Letter to the Editor - Reply to "Advancing AI Ethics Frameworks in Drug Development: Global Applicability, Practical Challenges, and Dynamic Governance".
Timothé Ménard, Katrina A Bramstedt

Ther Innov Regul Sci· September 2025

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The Adoption and Use of Artificial Intelligence and Machine Learning in Clinical Development.
Mary Jo Lamberti, Maria I Florez, Hana Do, Stephanie Rosner, Timothe Menard

Ther Innov Regul Sci· September 2025

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Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development.
Timothé Ménard, Katrina A Bramstedt

Ther Innov Regul Sci· May 2025

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Adaptive Machine Learning Systems in Medicine: The Post-Authorization Phase.
Katrina A Bramstedt, Timothé Ménard

Am J Bioeth· October 2024

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An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium.
Björn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, Frederik Collin, Annett Keller

Ther Innov Regul Sci· July 2024

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Good quality practices for artificial intelligence in genetics.
Timothé Ménard

Eur J Hum Genet· September 2022

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Advanced analytics for clinical trial quality: Commentary on 'Can quality management drive evidence generation?'.
Timothé Ménard

Clin Trials· June 2022

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Inferences of Mutational Status for Variants Detected From Tumor-Only Sequencing-A Quality Assurance Strategy.
Timothé Ménard

JCO Precis Oncol· June 2022

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Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing.
Björn Koneswarakantha, Timothé Ménard

Ther Innov Regul Sci· May 2022

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Correspondence on "Artificial intelligence-assisted phenotype discovery of fragile X syndrome in a population-based sample" by Movaghar et al.
Timothé Ménard

Genet Med· March 2022

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Open Source Analytics App for Clinical Trials: Letter to the Editor-A Novel App for Insights into Laboratory Data of Clinical Trials.
Björn Koneswarakantha, Timothé Ménard

Ther Innov Regul Sci· November 2021

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Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development.
Timothé Ménard, Alaina Barros, Christopher Ganter

Ther Innov Regul Sci· September 2021

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Bayesian Modeling for the Detection of Adverse Events Underreporting in Clinical Trials.
Yves Barmaz, Timothé Ménard

Drug Saf· September 2021

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Cross-company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry group.
Timothé Ménard, Kyle Young, Laura Siegel, Jennifer Emerson, Robert Studt

CPT Pharmacometrics Syst Pharmacol· August 2021

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Clinical Quality in Cancer Research: Strategy to Assess Data Integrity of Germline Variants Inferred from Tumor-Only Testing Sequencing Data.
Timothé Ménard, Donato Rolo, Björn Koneswarakantha

Pharmaceut Med· July 2021

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Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19.
Timothé Ménard

Ther Innov Regul Sci· May 2021

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Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning.
Min Zou, Yves Barmaz, Melissa Preovolos, Leszek Popko, Timothé Ménard

Ther Innov Regul Sci· January 2021

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Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting.
Björn Koneswarakantha, Yves Barmaz, Timothé Ménard, Donato Rolo

Drug Saf· January 2021

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Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example.
Timothé Ménard, Rich Bowling, Pooja Mehta, Björn Koneswarakantha, Eileen Magruder

Contemp Clin Trials Commun· December 2020

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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, Yves Barmaz, Rich Bowling

Ther Innov Regul Sci· September 2020

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Follow-Up on the Use of Machine Learning in Clinical Quality Assurance: Can We Detect Adverse Event Under-Reporting in Oncology Trials?
Timothé Ménard, Björn Koneswarakantha, Donato Rolo, Yves Barmaz, Leszek Popko

Drug Saf· March 2020

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Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning.
Timothé Ménard, Yves Barmaz, Björn Koneswarakantha, Rich Bowling, Leszek Popko

Drug Saf· September 2019

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