Search

Your search keyword '"Gittleman, Dean"' showing total 7 results
Start Over Author "Gittleman, Dean"
7 results on '"Gittleman, Dean"'

1. eSource records in clinical research: keeping it simple: how to satisfy regulatory concerns about EDC data integrity and site controls over its source records

Author

Mitchel, Jules T., Helfgott, Jonathan, Haag, Tom, Cappi, Silvana, Dunn, Imogene McCanless, Kim, Yong Joong, Choi, Joonhyuk, Cho, Timothy, and Gittleman, Dean

Subjects
United States. Food and Drug Administration -- Health policy, Regulatory compliance -- Methods, Clinical trials -- Methods -- Information management -- Laws, regulations and rules, General interest, Health
Abstract

There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process. In 2008, the Clinical Trial Transformational Initiative (CTTI), a public-private partnership [...]

Published
2015

3. Three-pronged approach to optimizing trial monitoring: study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry

Author

Mitchel, Jules T., Cho, Timothy, Gittleman, Dean A., Markowitz, Judith M. Schloss, Kim, Yong Joong, Choi, Joonhyuk, Hamrell, Michael R., Nora, Sergio Dalla, and Carrara, Dario

Subjects
United States. Food and Drug Administration -- Standards, Sentinel health events -- Methods, Risk assessment -- Analysis, Clinical trials -- Usage, General interest, Health
Abstract

[PEER REVIEW] In order to support the transformation of how the pharmaceutical industry manages the performance of clinical trials, in 2013, the Food and Drug Administration (FDA) issued its final [...]

Published
2014

4. Risk-based approaches: the eClinical Forum risk based monitoring taskforce offers some best practices for ensuring clinical data quality

Author

Brothers, Julie M., Gittleman, Dean A., Haag, Thomas, Kalinowski, Darlene, Karageorgos, Ioannis, King, Robert, Lucero, Lisa, McCann, Debbie, McHale, Paula, Mitchel, Jules, Nadolny, Patrick, Sibbald, Selina, and Wilson, Brett

Subjects
Best practices -- Methods, Clinical trials -- Quality management -- Laws, regulations and rules, Risk management -- Methods, Pharmaceutical research -- Quality management -- Laws, regulations and rules, Government regulation, Risk management, General interest, Health
Abstract

Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials. The reasons, while diverse, [...]

Published
2013

5. Electronic Data Capture in Clinical Trials using Service Providers

Author

Yeomans, Alan, Arnoult, Michel, Grass, Andreas, Leisegang, Rüdiger, Hughes, Steven, Benatti, Renata, Kalinowski, Darlene, Gratton, Richard, Yiannis Karageorgos, Andrus, Jonathan, Daemon Lincoln, Gonzales, Begoña, King, Linda S, Jakobsen-Martin, Bonnie J, Neehar Gupta, Arnera, Valdo, Beckstrom, Karin, O’Donnell, Rhona, Dairine Dempsey, Muehlhausen, Willie, Schwarz-Boeger, Ulrike, Marker, Niels, Nolan, Frances, Coran, Phil, Quarm, David, Haag, Tom, Koch, Thomas, Gold, Andrew, Deepshree Sarda, Riley, Mark, Schepers, Aldo, Elnesr, Yasser, Kiehn, Susanne, Konopka, Neil, McHale, Paula, Basinger, Randall, Lowman, Doug, Sibbald, Selina, Gittleman, Dean, and Mitchel, Jules

Published
2016
Full Text
View/download PDF

6. Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

Author

Yeomans, Alan, Arnoult, Michel, Grass, Andreas, Leisegang, Rüdiger, Hughes, Steven, Benatti, Renata, Kalinowski, Darlene, Gratton, Richard, Yiannis Karageorgos, Andrus, Jonathan, Daemon Lincoln, Gonzales, Begoña, King, Linda S, Jakobsen-Martin, Bonnie J, Neehar Gupta, Arnera, Valdo, Beckstrom, Karin, O’Donnell, Rhona, Dairine Dempsey, Muehlhausen, Willie, Schwarz-Boeger, Ulrike, Marker, Niels, Nolan, Frances, Coran, Phil, Quarm, David, Haag, Tom, Koch, Thomas, Gold, Andrew, Deepshree Sarda, Riley, Mark, Schepers, Aldo, Elnesr, Yasser, Kiehn, Susanne, Konopka, Neil, McHale, Paula, Basinger, Randall, Lowman, Doug, Sibbald, Selina, Gittleman, Dean, and Mitchel, Jules

Published
2016
Full Text
View/download PDF

7. Risk-Based Approaches.

Author

Brothers, Julie M., Gittleman, Dean A., Haag, Thomas, Kalinowski, Darlene, Karageorgos, Ioannis, King, Robert, Lucero, Lisa, McCann, Debbie, McHale, Paula, Mitchel, Jules, Nadolny, Patrick, Sibbald, Selina, and Wilson, Brett

Subjects
*CLINICAL trials monitoring, *MEDICAL research, *MEDICAL technology, *MEDICAL ethics, *DATA
Abstract

The article focuses on the regulatory and business assumptions for adopting tools and processes that are related to monitoring and can provide higher quality trial data at a lower cost. It mentions that the eClinical forum risk-based monitoring taskforce provides effective methods for assuring the quality of the clinical data. It also provides certain beneficial details that are related to the elements that can be considered for evolving risk-based approaches to clinical trial monitoring.

Published
2013

Catalog

Books, media, physical & digital resources
See catalog results