clinical trial reporting Archives - TrialAssure

National Cancer Institute Clinical Trials Reporting Program (NCI CTRP) EMA published a 27-page report this week titled Clinical data publication (Policy 0070) report Oct 2016 – Oct 2017 on the first year for implementing the policy. In that time, more than 3,000 clinical documents, or 1.3 million pages, were made publicly available on the Clinical Data Publication (CDP) website. The effort was described as “productive” and users of the website are satisfied, based on their reports. As more experience is gained, EMA expects to work with submitters on the quality of anonymization reports. trialassure software pharmatech medtech

This week in transparency news: January 25 – February 7, 2020

by Staff Writer | February 2020

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of previous noncompliance, and/or submitting misleading or false information to ClinicalTrials.gov. While the FDA has not previously begun issuing fines to pharmaceutical companies, this guidance brings that reality one step closer. Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking. Zach Weingarden, Product Solutions Manager, TrialAssure

How TrialAssure Gathers Client Feedback to Build Stronger Clinical Trial Transparency Software

by Zach Weingarden | June 2019

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trialassure clinical trial transparency news

This week in transparency news: February 23 – March 1, 2019

by Staff Writer | March 2019

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Should people share their DNA for drug development purposes? – USA Today Many people don’t realize that sharing a DNA sample with Ancestry.com, 23andMe and others can result in their data being shared. However, this week, the companies pledged that they would disclose when data is shared with corporations or the government. With a $300 million investment by GSK in 23andMe, they state that approximately 80 percent of customers have agreed to share their DNA data. This data is being de-identified before it is shared.

This week in transparency news: February 9 – February 15, 2019

by Staff Writer | February 2019

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This week in transparency news: October 27 – November 2, 2018

by Staff Writer | November 2018

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