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A New Box

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! You got a password? A sponsor recently presented some site audit findings at an investigator meeting and I think two of them are definitely worth repeating:. 1) The site has a number of personnel that were granted IVRS/EDC access, but never changed the initial passwords or accessed the system at least once. So what's the big deal? Facebook and the FDA. The idea behi...

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A New Box | anewbox.blogspot.com Reviews

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A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! You got a password? A sponsor recently presented some site audit findings at an investigator meeting and I think two of them are definitely worth repeating:. 1) The site has a number of personnel that were granted IVRS/EDC access, but never changed the initial passwords or accessed the system at least once. So what's the big deal? Facebook and the FDA. The idea behi...

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A New Box | anewbox.blogspot.com Reviews

https://anewbox.blogspot.com

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! You got a password? A sponsor recently presented some site audit findings at an investigator meeting and I think two of them are definitely worth repeating:. 1) The site has a number of personnel that were granted IVRS/EDC access, but never changed the initial passwords or accessed the system at least once. So what's the big deal? Facebook and the FDA. The idea behi...

INTERNAL PAGES

anewbox.blogspot.com

1

A New Box: December 2009

http://anewbox.blogspot.com/2009_12_01_archive.html

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! Keep your Guard Up. Two years ago Quintiles launched iGuard. A personalized medication monitoring service for patients that doubles as a clinical trial recruitment tool. The multinational CRO has reported (as reported by PharmaTimes. This system put together by Quintiles is a better example of how trial recruitment and retention should be researched and developed&#4...

2

A New Box: The CROs can get it too

http://anewbox.blogspot.com/2009/12/cros-can-get-it-too.html

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! The CROs can get it too. Read the monitoring letter in its entirety here. Subscribe to: Post Comments (Atom). What's New at PharmaShark? Uarr; Grab this Headline Animator. Raleigh, NC, United States. View my complete profile. There was an error in this gadget. Enter your email address:. A New Box Archives. Keep your Guard Up. I got the right temperature.

3

A New Box: June 2009

http://anewbox.blogspot.com/2009_06_01_archive.html

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! Who's Going to Rescue the Rescue? An FDA advisory committee recommended today to lower the maximum single dose of acetaminophen for adults from 1000mg to 650mg. As described in " OvertheCounterToday. The same panel also voted in favor of decreasing the maximum daily dose of APAP. I don't know the answer to that (perhaps statisticians can answer that one), but I woul...

4

A New Box: September 2009

http://anewbox.blogspot.com/2009_09_01_archive.html

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! This Way or That. One problem with auditing and monitoring is that there is too much inconsistency as to how things should be documented. A prime example is with date formats. All of the following are ways of documenting the ninth day of September in the year 2009:. But which one is correct? Screen me, please. Would you be likely to take your business there? One com...

5

A New Box: Spread the Word

http://anewbox.blogspot.com/2010/01/spread-word.html

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! The FDA has taken what I believe to be an important step to increase public awareness of what exactly the agency does by creating a section of their website called " FDA Basics. Which contains some information about the drug approval process as well as enrolling in clinical trials. Http:/ www.fda.gov/AboutFDA/Basics. Subscribe to: Post Comments (Atom).

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pharmashark.blogspot.com

PharmaShark: Novo's time to shine

http://pharmashark.blogspot.com/2010/01/novos-time-to-shine.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Novo's time to shine. Yesterday the FDA approved a potential blockbuster diabetes drug manufactured by Novo Nordisk. Read more about the approval and Victoza here. What happens when two big pharma companies merge? Well you get lots of job cuts and a bigger-than=necessary development pipeline. That's exactly what happened with Pfizer. Enter your email address:.

pharmashark.blogspot.com

PharmaShark: February 2010

http://pharmashark.blogspot.com/2010_02_01_archive.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Have a heart, it's V-Day! It's that time of year again.Valentine's Day! In honor of that, Seeking Alpha. Put together some nice data on 6 companies that work in the cardiac device market and in the website's opinion are making the right decisions. The basic take home message: Abbott and Edwards Life Sciences look like the strongest buys of the six. Reported ...

pharmashark.blogspot.com

PharmaShark: another IPO...

http://pharmashark.blogspot.com/2010/02/another-ipo.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. The Times reports here. And finally for some lighter reading:. Here's a nice piece by Fierce Biotech on the top 10 deals in 2009. And one from BNet on upcoming FDA decisions and happenings in the biotech world. Subscribe to: Post Comments (Atom). What's Going on at A New Box? Uarr; Grab this Headline Animator. There was an error in this gadget.

pharmashark.blogspot.com

PharmaShark: November 2009

http://pharmashark.blogspot.com/2009_11_01_archive.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Zetia down, out? Next up, is this really news? Almost every vaccine manufacturer has conducted trials on cell-based production technology, but there has been little to no regulatory progress on them yet. Read the WSJ piece for yourself. Read more from the BBC here. Read more on the IPO here. Speaking of IPO's.Cumerland, which held its own IPO earlier thi...

pharmashark.blogspot.com

PharmaShark: Time's Up!

http://pharmashark.blogspot.com/2010/02/times-up.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Everyone's talking about the upcoming patent cliff next year.well the downward slope towards the edge starts this year:. See this nifty little article by Fierce Pharma on the patent expirations for 2010. While that patent cliff is enough to turn investors white, Elan. Reuters reports here on the profit projection. Reuters discusses Crucell here. Have a heart...

pharmashark.blogspot.com

PharmaShark: Tysabri Back in the News

http://pharmashark.blogspot.com/2010/02/tysabri-back-in-news.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Tysabri Back in the News. Read the FDA advisory here. Read more at NJ.com. Optimer has created a new antibiotic for the common bacteria C.diff that seems to be at least as effective as a commonly used treatment for the potentially lethal infection. What does this mean for Optimer? Xconomy offers insight here. Subscribe to: Post Comments (Atom).

pharmashark.blogspot.com

PharmaShark: AZ drops the ax

http://pharmashark.blogspot.com/2010/01/az-drops-ax.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. AZ drops the ax. Read more in the UK publication, the Telegraph. It's usually small biotechs that make news when they announce plans to go public. This time though, it's a bit different as Otsuka. The Reuters article is here. Subscribe to: Post Comments (Atom). What's Going on at A New Box? Uarr; Grab this Headline Animator. There was an error in this gadget.

pharmashark.blogspot.com

PharmaShark: Have a heart, it's V-Day!

http://pharmashark.blogspot.com/2010/02/have-heart-its-v-day.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Have a heart, it's V-Day! It's that time of year again.Valentine's Day! In honor of that, Seeking Alpha. Put together some nice data on 6 companies that work in the cardiac device market and in the website's opinion are making the right decisions. The basic take home message: Abbott and Edwards Life Sciences look like the strongest buys of the six.

pharmashark.blogspot.com

PharmaShark: The Day After...

http://pharmashark.blogspot.com/2010/02/day-after.html

Not so detailed news/notes/analysis of happenings in the pharma/biotech/clinical research realm.a chip off the New Box. Brought to you by A New Box. Read more here in Xconomy. Read more here fromhttp:/ www.reuters.com/article/idUSN0313639620100203. The answer is that Teva is treating its drug as a entirely new product with a new BLA.interesting idea. If the FDA looks favorably on this new biologic, expect Teva to pull in some serious cash. Fierce Biotech reports on the situation here. Head to head trials.

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A New Box

A New Box is opening. Refreshing commentary and ideas on the world of clinical research. Don't think outside the box, think about A New Box! You got a password? A sponsor recently presented some site audit findings at an investigator meeting and I think two of them are definitely worth repeating:. 1) The site has a number of personnel that were granted IVRS/EDC access, but never changed the initial passwords or accessed the system at least once. So what's the big deal? Facebook and the FDA. The idea behi...

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