Trial Data Transparency, Management Blog | TrialAssure

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FORBES: How Blockchain Will Revolutionize The Pharmaceutical Industry

by Staff Writer | December 2018

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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: November 17-30, 2018

by Staff Writer | November 2018

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trialassure clinical trial transparency news

This week in transparency news: November 10-16, 2018

by Staff Writer | November 2018

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of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 Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking.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

Common clinical trial transparency questions, answered!

by Staff Writer | November 2018

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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: November 3-9, 2018

by Staff Writer | November 2018

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

by Staff Writer | November 2018

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This week in transparency news: October 13-26, 2018

by Staff Writer | October 2018

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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: September 29 – October 12, 2018

by Staff Writer | October 2018

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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

Questions answered on FDA’s draft guidance on civil money penalties for ClinicalTrials.gov

by Staff Writer | October 2018

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