Aug 14, 2009

Why do clinical trials in the US?

I'm searching for a reason and here is the one I came up with:
  • The world expert resides in the US and you really need her on your team
I couldn't come up with any more concrete reasons. Maybe you don't know the regulations oversees, but that can be easily taken care of, search the web or buy a book, it will save you in the long run. Even if most of your sales are in the US, I don't think a foreign trial hurts you (as long as your sponsor is halfway respected of course).

If you have a standard device, almost anywhere will do. If you have a new device, find a well respected doctor in Europe and see what kind of magic you can work there at half the regulatory burden and less lawsuit liability.

(Photo from Karen Horton)

11 comments:

  1. JeffSeptember 28, 2009 at 7:19 AM

    I just discovered your blog here, what a great resource for industry news and happenings. We, as a company just started a blog on medical device package testing issues. It's always great to find other good resources in the industry to read. Thanks for sharing.

    http://testedandproven.wordpress.com

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  2. DaveOSeptember 30, 2009 at 1:12 PM

    Nice stuff. I just read your post on labeling from 2007 and as a label and packaging printer it was insightful getting the unvarnished thoughts on labels and labeling. Like Jeff from DDL, I write a blog on labeling. A bit more humor than most but I guess you gotta have some fun at work also.
    Dr O
    http://awblogger.wordpress.com/

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  3. Kim AOctober 5, 2009 at 6:53 PM

    I don't have much experience with clinical trials. I've actually done the translations of them only but I can tell you that I have worked with some major pharmaceutical companies and they do both. Supposedly, the companies that do work outside of the USA is because of the lighter government regulations overseas. They would rather have the results translated for FDA submission afterwards.

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  4. Maria DeviceDecember 3, 2009 at 10:21 PM

    Hey its a very informative resource, I found it to be very interesting, keep posting.

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  5. Medical Device Market ReportsJanuary 8, 2010 at 8:48 PM

    Thank you for the post, I found it to be interesting and informative.

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  6. AmyJanuary 28, 2010 at 10:37 PM

    Great blog. I hope you will continue to write.

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  7. Jason MonroeJanuary 30, 2010 at 4:18 PM

    I'm sure the regulatory system of the US is complex but if you can make it through the system over here then the rest of the world is easy.

    On a personal note, I am interested in exchanging links with you from my medical blog (medicalnoise.wordpress.com) over to your medical blog. Let me know how you want to be linked and I can get you listed in a few days.

    On a business note, I know the owner over at JRS Medical and was wondering if they could get listed in this blog under a category like Medical Resources or something like that for a fee? I’m sure they would be open to a blog post reviewing their website or some of their products too? They can pay you by PayPal for your trouble.

    Let me know if you’re interested in either. Look forward to hearing back from you.

    --
    Jason
    (long time diabetic)
    Let's practice love, acceptance, & forgiveness

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  8. AnonymousMarch 29, 2010 at 3:41 PM

    Are you going to continue posting or is this blog DEAD?

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  9. AnonymousApril 1, 2010 at 7:43 PM

    THIS BLOG IS DEAD.
    You can tell because
    1) No new posts for 6 months
    2) Most comments are from Spammers.

    This blog used to be a good source of information.

    R.I.P.

    ReplyDelete
  10. RankinDecember 30, 2012 at 6:28 PM

    Clinical trials are important to make sure the products are safe.

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  11. Projesan Hospital Furniture CoOctober 25, 2014 at 2:17 AM

    Nice Blog. I wish I do like that.
    Thats very helpfuly.

    ReplyDelete