Blog Archives - Page 12 of 17 - TrialAssure

The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of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 Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking.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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Policy 0070 submissions pending suspension in Europe – DIA Communities Due to EMA’s relocation from London to Amsterdam, the “launch of new procedures (related to clinical data publication under Policy 0070) will be temporarily suspended already as of 1 August 2018,” according to an email shared by Melanie Carr, Head of Stakeholders and Communication Division and Head of Corporate Stakeholders Department ad interim, European Medicines Agency (EMA). It is noted that all redaction proposal packages submitted after July 31st will be temporarily suspended. A press release with full details is said to be released next week.

This week in transparency news: June 15 – June 21, 2019

by Staff Writer | June 2019

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The U.S. Senate had voted in favor of an opioid bill that expands Open Payments to include payments made to Nurse Practitioners, Physician Assistants, Nurse Midwifes, Nurse Anesthetists, and Clinical Nurse Specialists, in addition to current physician reporting requirements. This will go into effect beginning January 1, 2022. Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

This week in transparency news: June 8 – June 14, 2019

by Staff Writer | June 2019

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Outsourcing-Pharma released a State of the Industry report that sheds light on the global pharmaceutical industry. One of the key findings in the report showed that more than half of survey respondents believe that industry initiatives will lead to greater transparency. The report points to a new pilot program launched earlier this year by the FDA to increase transparency. Clinical Trial Transparency Software client feedback

This week in transparency news: June 1 – June 7, 2019

by Staff Writer | June 2019

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CSR pilot FDA releases first clinical study report in data transparency pilot program trialassure fdaaa section 801 requirements fdaaa trials tracker

This week in transparency news: May 25 – May 31, 2019

by Staff Writer | May 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: May 18 – May 24, 2019

by Staff Writer | May 2019

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This week in transparency news: May 11 – May 17, 2019

by Staff Writer | May 2019

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trialassure clinical trial transparency news

This week in transparency news: April 27 – May 3, 2019

by Staff Writer | May 2019

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The U.S. Senate had voted in favor of an opioid bill that expands Open Payments to include payments made to Nurse Practitioners, Physician Assistants, Nurse Midwifes, Nurse Anesthetists, and Clinical Nurse Specialists, in addition to current physician reporting requirements. This will go into effect beginning January 1, 2022. Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

This week in transparency news: April 20 – April 26, 2019

by Staff Writer | April 2019

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