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18 results on '"Helfgott, Jonathan"'

1. The Transformation of Clinical Trials: From writing on papyrus to the world of technology

Author

Mitchel, Jules T., Gogates, Greg, Yeomans, Alan, Xie, Tai, Rojas, Luis A., Helfgott, Jonathan S., and Tantsyura, Vadim V.

Subjects
Clinical trials, Data entry, General interest, Health
Abstract

The recent evolution within the pharmaceutical industry to the use of technologies associated with clinical trial data collection and storage is quite impressive. Even the risk-averse clinical trial sites are [...]

Published
2022

2. Analysis: FDA's COVID-19 Accelerated Pathways: Lessons learned from FDA's current process and proposed alternative review strategies

Author

Mitchel, Jules T., Rojas, Luis A., and Helfgott, Jonathan S.

Subjects
United States. Food and Drug Administration, Pfizer Inc., Patient compliance, Vaccines, Pharmaceutical industry, General interest, Health
Abstract

At the October 2021 DIA conference on Digital Technologies in Clinical Trials, Pfizer reported the following timeline for the Pfizer-BioNTech COVID-19 vaccine clinical program: On May 4, 2020, the Phase [...]

Published
2021

3. Regulatory considerations for 21st century paperless trials: how to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review

Author

Mitche, Jules and Helfgott, Jonathan

Subjects
United States. Food and Drug Administration -- Powers and duties, Clinical trial management software -- Usage -- Laws, regulations and rules -- Research, Government regulation, General interest, Health
Abstract

The FDA and other regulatory bodies have issued multiple guidance documents addressing technology tools that are used in clinical trials. FDA guidance documents include computerized systems; (1) software validation; (2) [...]

Published
2017

6. Baseline neuroimaging characteristics in the randomized pivotal study of renew NCP‐5 for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia of the Alzheimer's type

Author

Salat, David H., primary, Almaktoum, Randa, additional, Helfgott, Jonathan S., additional, Helmer, Karl G., additional, Jacoby, John, additional, Jang, Ikbeom, additional, Juttukonda, Meher R., additional, Loveley, Allison, additional, Moreno, Tom, additional, Peled, Noam, additional, Stufflebeam, Steven, additional, and Greve, Douglas N., additional

Published
2021
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7. Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies – A workshop report

Author

Solomon, Howard M., Makris, Susan L., Alsaid, Hasan, Bermudez, Oscar, Beyer, Bruce K., Chen, Antong, Chen, Connie L., Chen, Zhou, Chmielewski, Gary, DeLise, Anthony M., de Schaepdrijver, Luc, Dogdas, Belma, French, Julian, Harrouk, Wafa, Helfgott, Jonathan, Henkelman, Mark R., Hesterman, Jacob, Hew, Kok-Wah, Hoberman, Alan, Lo, Cecilia W., McDougal, Andrew, Minck, Daniel R., Scott, Lelia, Stewart, Jane, Sutherland, Vicki, Tatiparthi, Arun K., Winkelmann, Christopher T., Wise, David L., Wood, Sandra L., and Ying, Xiaoyou

Published
2016
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8. 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

11. Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Author

Coran, Philip, primary, Goldsack, Jennifer C., additional, Grandinetti, Cheryl A., additional, Bakker, Jessie P., additional, Bolognese, Marisa, additional, Dorsey, E. Ray, additional, Vasisht, Kaveeta, additional, Amdur, Adam, additional, Dell, Christopher, additional, Helfgott, Jonathan, additional, Kirchoff, Matthew, additional, Miller, Christopher J., additional, Narayan, Ashish, additional, Patel, Dharmesh, additional, Peterson, Barry, additional, Ramirez, Ernesto, additional, Schiller, Drew, additional, Switzer, Thomas, additional, Wing, Liz, additional, Forrest, Annemarie, additional, and Doherty, Aiden, additional

Published
2019
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12. Medical device compliance: a probability sampling assessment by FDA takes a look at compliance in the medical device world

Author

Marcarelli, Michael E. and Helfgott, Jonathan S.

Subjects
United States. Food and Drug Administration -- Laws, regulations and rules, Medical equipment -- Product development -- Laws, regulations and rules, Medical test kit industry -- Product development -- Laws, regulations and rules, Medical equipment and supplies industry -- Product development -- Laws, regulations and rules, Clinical trials -- Laws, regulations and rules, Physiological apparatus -- Product development -- Laws, regulations and rules, Government regulation, General interest, Health
Abstract

The goal of the Probability Sampling Study (P.S.S.) is to evaluate risk factors that contribute to the state of regulatory compliance for medical device clinical investigations. The results of the [...]

Published
2009

15. Regulatory Considerations for 21st Century Paperless Trials.

Author

Mitchel, Jules and Helfgott, Jonathan

Subjects
*CLINICAL trials, *CLINICAL medicine research, *MEDICAL research, *COMPUTERS in the health care industry, *INFORMED consent (Medical law), *COMPUTER software
Abstract

The article reports on regulatory considerations for a paperless clinical trial. Topics discussed include reason the pharmaceutical industry has been risk-averse in adopting modern-day technology tools that could support clinical trials, examples of regulated clinical trial software being used which include electronic data capture systems and electronic informed consent, and critical questions to be asked concerning the intended use of the software.

Published
2017

16. Medical Device Compliance.

Author

Marcarelli, Michael E. and Helfgott, Jonathan S.

Subjects
*PROBABILITY theory, *STATISTICAL sampling, *CLINICAL trials, *MEDICAL research personnel
Abstract

The article focuses on the Probability Sampling Study (PSS) that aims to evaluate the regulatory compliance for medical device clinical investigations of the Food and Drug Administration (FDA) in the U.S. The results of the PSS are use to channel the limited FDA resources into several areas of concern. The data from the PSS may be used to support the need for a higher level of attention to sponsor monitoring and investigator training.

Published
2009

18. Understanding the US Food and Drug Administration's May 2007 Guidance - 'Computerized Systems Used in Clinical Investigations'.

Author

Helfgott, Jonathan S.

Subjects
*COMPUTER access control, *CONTRACT research organizations, *INSTITUTIONAL review boards, *DOCUMENTATION, *SOFTWARE documentation, *CONFIDENTIAL communication access control, *MANAGEMENT
Abstract

This article highlights the major topics covered in the guidance entitled 'Computerized Systems Used in Clinical Investigations' issued by the US Food and Drug Administration (FDA) in May 2007. The guidance provides recommendations to contract research organisations, data management centres, clinical investigators and institutional review boards on the proper use of computer systems. It is intended to assist sponsors of FDA-regulated clinical research in ensuring confidence in the reliability, quality and integrity of electronic source data and source documentation (i.e. electronic records). Recommendations in the guidance include training, internal/external security safeguards, system features such as audit trails, direct entry of data, retrieving data, dependability system documentation, system controls and change controls. [ABSTRACT FROM AUTHOR]

Published
2010

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