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18 results on '"Helfgott, Jonathan"'

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

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

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

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

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

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

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

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

15. Regulatory Considerations for 21st Century Paperless Trials.

16. Medical Device Compliance.

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

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