We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter

Armando Jose Velasquez, aka “Money,” 27, of East Chicago, Indiana, was sentenced today to serve 305 months in prison on federal racketeering charges relating to a Dec. 3, 2011, attempted murder

Nicholaus J. Rodgers, 31, of Shady Cove, Oregon, pleaded guilty in federal court in Denver to a felony conspiracy charge stemming from the assistance he provided to an outfitter who sold illegal mountain lion and bobcat hunts in Colorado and Utah, the Justice Department announced

Christopher W. Loncarich, 55, of Mack, Colorado, pleaded guilty in federal court in Denver to a felony conspiracy charge stemming from his sale of outfitting services for illegal mountain lion and bobcat hunts in Colorado and Utah, the Justice Department announced

A former Coöperatieve Centrale Raiffeisen-Boerenleenbank B.A. (Rabobank) Japanese Yen London InterBank Offered Rate (LIBOR) submitter pleaded guilty today for his role in a conspiracy to commit wire and bank fraud by manipulating Rabobank’s Yen LIBOR submissions to benefit trading positions

Chairman Carper, Ranking Member Coburn and distinguished members of the committee, thank you for inviting me to speak with you today about the Department of Justice’s role in supporting state, local and tribal law enforcement agencies.

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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The American Herbal Products Association submitted nearly 100 pages of comments to the Food and Drug Administration Center for Food Safety and Applied Nutrition identifying ways to improve regulations, guidance documents and enforcement practices to better protect public health.

By Laurie Meehan

“I can’t get the IWRS to assign a kit number.”

“My ECG reports take forever to come back from the Core Lab.”

“The eCRF won’t let me create a new subject.”

“This stupid machine is blinking an error code again.”

Sound familiar?  Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites.  Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before.  And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.  



And how are problems like these typically resolved?  Someone at the study site works his/her way through a list of maybe 20 or more vendor contact numbers, places a call, navigates a series of menu options, and hopefully gets directed to someone who can help.  And that assumes the site calls the right company; with tightly integrated systems, it’s not always obvious in which vendor’s system the problem lies.  This is frustrating for sites.  It takes time.  It costs money (since “vendor wrangling” is seldom sufficiently covered in the budget).  And it keeps study staff from doing what study staff does best – run the study, work with the study volunteers, and keep them safe.

So what’s the solution? 

Hint: It’s Not Training
Calm down.  Of course, adequate training on equipment and systems is important. But training doesn’t solve every problem.  Training doesn’t keep equipment from malfunctioning.  Training doesn’t ensure vendors deliver what and when they’ve promised.  Training can’t anticipate every situation nor address an unusual site circumstance.  And training doesn’t turn people into infallible little machines; we make mistakes.  And so, in all these cases, we’re back to site personnel interacting with perhaps scores of vendors, by phone or email, all over the world.

The Solution: a Single Point of Contact
Q: How do you help sites interact with dozens of vendors?
A:  You don’t.  You do it for them.  Establish a single point of contact within the Sponsor* organization for a site to call when vendor issues arise. 

Why is this a good idea when the expertise to resolve the issue lies with the vendor?  Why is this a good idea when the introduction of a middleman may result in some inefficiencies?

Excellent questions.  Here are our responses. 

• Better Vendor Oversight.  When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track vendor performance.  Are there vendors that provide low-quality solutions, are repeatedly late, or difficult to deal with?  At best, these vendors are wasting time and money, and aren’t good for business (let alone site relations).  At worst, these vendors are jeopardizing subject safety or study data integrity, and require immediate Sponsor intervention.

• Better Site Oversight.  When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track site performance.  Are there sites that routinely use equipment and computer systems incorrectly?  (Yes, now’s the time for that training.)  Are there high-performing sites that are able to work independently?  This information has always been important, but in an RBM paradigm, it’s essential.  Adaptive monitoring plans rely on on-going site performance measurements so Sponsors can adjust resources accordingly.  A reduction in monitoring visits means less opportunity to assess a site’s comfort level with study technology.  The corollary of “if it ain’t broke, don’t fix it” is “if you don’t know it’s broke, you can’t fix it.”

• Ability to Identify Pervasive Problems. After the third or fourth site reports the same problem, it’s clear that this is not an isolated occurrence.  Knowing that, the Sponsor can work with the vendor to resolve the problem before other sites experience the same troubles.

• Better Functioning Sites.  We have a saying: “The Site Comes First."™  In our experience, all things being equal, Sponsors that put their sites first -- make things as easy as possible for the study coordinators -- get the best results.  They also build the good relationships that keep the best sites coming back to work on future studies.

• Better Functioning Vendors.  The efficiencies for the vendor here are clear.  Who wouldn’t rather interact with a single point of contact than field individual calls from multiple study sites?  Plus, with far fewer players, miscommunicating both problem descriptions and problem solutions is less likely to occur.  The Sponsor contact and the vendor contacts will eventually settle into common terminology and build a history regarding past issues and resolutions.

What Do You Think?
We know that not everyone espouses this idea, and we recognize there are probably other effective processes out there.  Sponsors, how do you help your sites deal with multiple vendors?  Sites, do you have experiences and/or suggestions you can share?  (Be kind, anonymize!)  Leave a comment here, visit our website, or send us an email.




____________________
*When we use the term “Sponsors” in this post, we’re including CROs that take on Vendor Management responsibilities on behalf of Sponsors.

BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor.

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.

Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat.

Researchers found that temperature extremes previously thought to be rare have been recorded more than 1,000 times in 40 years.

The committee will examine the merits and demerits of various dates for the commencement of the its report by 31 December 2016.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Jarno Trulli has hit out at the growing influence of so-called 'pay drivers' in Formula One, accusing them of being 'less committed'

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.

Apr 20, 2020

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.