Trial Data Transparency, Management Blog | TrialAssure

Philippine Health Research Registry (PHRR) trialassure

REGISTRY SNAPSHOT: Philippine Health Research Registry (PHRR)

by Staff Writer | July 2019

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German Clinical Trials Register (DRKS) trialassure

REGISTRY SNAPSHOT: German Clinical Trials Register (DRKS)

by Staff Writer | July 2019

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This week in transparency news: June 22 – June 28, 2019

by Staff Writer | June 2019

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns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 Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking.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

REGISTRY SNAPSHOT: The Peruvian Clinical Trials Registry (REPEC)

by Staff Writer | 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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Pan African Clinical Trials Registry (PACTR) south africa trialassure

REGISTRY SNAPSHOT: Pan African Clinical Trials Registry (PACTR)

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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Federal Office for Safety in Health Care (BASG) vienna austria trialassure clinical trial registration disclosure transparency

REGISTRY SNAPSHOT: Federal Office for Safety in Health Care (BASG)

by Staff Writer | June 2019

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