Ethics/Regulatory

Charles River Laboratories International to pay $1.8M to settle False Claims Act allegations

Friday, March 24, 2017

Charles River Laboratories International has agreed to pay the U.S. government $1.8 million to settle claims that it violated the False Claims Act by improperly charging for labor and other associated costs that were not actually provided on certain NIH contracts, the Justice Department announced. Charles River is a for-profit corporation headquartered in Wilmington, Massachusetts. 

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NIH achieves milestone to accelerate multisite clinical studies

Friday, March 24, 2017

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

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Western IRB establishes single-IRB solution

Tuesday, March 21, 2017

Western Institutional Review Board (WIRB), a provider of ethical review of clinical research, announced the launch of its WIRB NIH Single Review Solution (SRS) for NIH-funded multi-site research. WIRB has an extensive background in reviewing clinical trials funded by NIH. Building upon status as the IRB of record for the majority of institutions that conduct clinical research in the U.S., WIRB NIH Single Review Solution will provide participating institutions the gold standard of research review.   

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Multi-sponsor trial results website launches

Monday, March 13, 2017

It wasn’t that long ago that patients just wandered away after a clinical trial wrapped up, never learning the results of the trial, never knowing whether or not their participation made any difference.

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FDA, EU drug inspectors ink Mutual Recognition Agreement

Monday, March 6, 2017

The U.S. and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

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Meet the newest ethical and legal challenge of obtaining and using data via the internet: The dark web

Wednesday, March 1, 2017

Are you afraid of the dark? What thoughts come to mind when you hear the word “dark”? Scary? Hidden? Sinister? Mysterious? Shadowy? The opposite of dark, of course, is “light” — and this signifies transparency, full disclosure, openness, and clarity. It is in this context that research professionals increasingly are using what is called the “dark web” to collect and use data for studies that are looking at activities that are often, but not always, illegal. What makes the dark web both intriguing and worrisome for researchers is not the kind of information it includes but rather the methods used to obtain the data (neither the usual search engines nor by hacking passwords).

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Certara Strategic Consulting awarded GLP compliant toxicokinetic test site certification

Wednesday, February 22, 2017

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that the Standards Council of Canada (SCC) has awarded Good Laboratory Practices (GLP) certification to its Certara Strategic Consulting (CSC) Montreal facility. CSC Montreal has passed the requisite inspection and study audits and is now recognized as a GLP compliant Toxicokinetic Test Site by SCC.

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