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1.
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.
Ther Innov Regul Sci
; 58(4): 591-599, 2024 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-38564178
2.
Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing.
Ther Innov Regul Sci
; 56(3): 433-441, 2022 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-35262899
3.
Clinical Quality in Cancer Research: Strategy to Assess Data Integrity of Germline Variants Inferred from Tumor-Only Testing Sequencing Data.
Pharmaceut Med
; 35(4): 225-233, 2021 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-34436760
4.
Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?
Ther Innov Regul Sci
; 54(5): 1227-1235, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32865805
5.
Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example.
Contemp Clin Trials Commun
; 20: 100662, 2020 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-33073053
6.
Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning.
Drug Saf
; 42(9): 1045-1053, 2019 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-31123940
7.
Open Source Analytics App for Clinical Trials: Letter to the Editor-A Novel App for Insights into Laboratory Data of Clinical Trials.
Ther Innov Regul Sci
; 55(6): 1107-1108, 2021 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34363199
8.
Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting.
Drug Saf
; 44(1): 121-123, 2021 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-33011933
9.
Follow-Up on the Use of Machine Learning in Clinical Quality Assurance: Can We Detect Adverse Event Under-Reporting in Oncology Trials?
Drug Saf
; 43(3): 295-296, 2020 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-31834590
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