In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

The best sports nutrition formulas designed to improve performance draw from a pool of ingredients researched for benefits to energy production, cognitive function and endurance both in general and specifically concerning muscles.

APEC officials announced this year’s winners for the annual APEC Business Efficiency and Success Target Awards, or BEST Awards - a collection of some of the best women-led businesses in the Asia-Pacific region.

The first Senior Officials Meeting for APEC Malaysia 2020 begins

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.

Catalent announces partnership with J&J to manufacture lead COVID-19 vaccine candidate, plans to hire 300 staff and manufacture 24/7.

April saw the company add new CEO, receive approval for lead ADC drug, and launch a public offering of stock.

Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]

Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

To read the whole article click on the headline

A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.

To read the whole article click on the headline

From fewer containers and reduced shift work at harbors to delays in planned maintenance in factories, the coronavirus pandemic is impacting global supply chains in myriad ways. FoodNavigator-USA (FNU) caught up with Jon Peters (JP), president at Beneo, a leading supplier of chicory root fiber, rice ingredients, and the specialty low-GI carbs Isomalt and Palatinose, to find out more.

By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

Many countries saw the coronavirus as a "rich man's disease" imported by overseas travelers. It has since hit marginalized groups the hardest.

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

U.S. health officials are monitoring for cases in the United States.

"Kids have moved on" to other nicotine vapes that will remain on the market.

Yokogawa Electric Corporation (TOKYO: 6841) announces the November 14 release of Plant Resource Manager (PRM) R4.03, the latest version of a software package in the OpreX Asset Management and Integrity family that facilitates the monitoring and control of plant operations by centralizing the management of large volumes of data from instrumentation and manufacturing equipment. PRM R4.03 features powerful device diagnostic functions that help to optimize plant maintenance and ensure safe operations.

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of Exaquantum R3.20, an enhanced version of its plant information management system (PIMS) software package in the OpreX Asset Operations and Optimization family.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has acquired capital in APB Corporation (APB), a pioneer in the development of a next-generation lithium-ion battery called the “All Polymer Battery,” with the aim of growing Yokogawa’s energy management system (EMS) business. The two companies have agreed that Yokogawa will provide energy management technology needed for the efficient operation and optimization of large-scale storage batteries.

Vikram Nirula, who joined in 2018 as managing director, will soon be leaving the company.

The post Buyout major Carlyle searches for new managing director in India appeared first on DealStreetAsia.

Flipkart Group CFO Emily McNeal has quit to pursue a career opportunity outside the Walmart Group.

The post India: Flipkart names Sriram Venkataraman as CFO of its commerce biz appeared first on DealStreetAsia.

The US-based venture capital firm routed the investment through its $60 million fund.

The post Mantra Capital makes maiden India investment in wellness startup SARVA appeared first on DealStreetAsia.

Mathematicians are developing forensics to identify political maps that disenfranchise voters

Use “negative reappraisal,” and understand you have work to do—time alone may not be enough

Dec 17, 2019

Julius Weitzdörfer’s earliest childhood memories are the major global events of 1986—the Space Shuttle Challenger explosion and the Chernobyl disaster. Looking back, he realizes that these events must have contributed to shaping his later research interests in managing technological risks. 

Mar 12, 2020

The Managing the Atom (MTA) project at the Harvard Kennedy School is seeking a full-time Research Associate to support research projects directed by Professor Matthew Bunn on a range of nuclear policy topics including strategic stability and the future of nuclear arms control, reducing the risks of nuclear theft and terrorism worldwide, stemming the spread of nuclear weapons, and addressing key constraints on and risks of nuclear energy. Reporting to the MTA co-principal investigator Prof. Matthew Bunn, the Research Associate will play a major role in researching and writing papers and reports in these areas.