Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.
The CRO industry developed mostly in the late 1990s when pharmaceutical R&D efforts became more complex and competition in rapidly-growing therapeutic areas increased. Particularly over the last few years, this forced the pharmaceutical industry to utilize ‘downsizing’ strategies more to concentrate resources on core skills. As industry margins come under increasing pressure, companies could begin outsourcing aspects of their development, manufacturing or marketing processes so as to concentrate on their core specialties.
Outsourcing has been particularly influential in the pharmaceutical industry as the success of a large pharmaceutical company depends on competence in fields as diverse as combinatorial chemistry, computer integrated manufacturing and marketing medicines directly to consumers.
External cost pressures have acted as a major driver for the pharmaceutical outsourcing market. At bottom, the outsourcing market has developed in response to the downward and upward cost pressures exerted on pharmaceutical manufacturers’ profit margins. Given that such pressures are likely to increase in the future, CROs will become more and more important strategic partners for pharmaceutical companies. It is, therefore, in the latter’s interest to consider probable developments in the CRO market and its major players.
This is the industry in which I am about to immerse myself in (if I can stay awake!!!)
I love you!
Cam
I will admit, I kind of dozed off in sentence #2.
ReplyDeleteMostly, because I realized you were taking about "Pharmaceuticals", and not "Harmaceuticals".
good luck, Sweety!
ReplyDeleteI'm sure you'll do great and wow them with your wit and charm.
Love you too,Mou!
OMG...it is a bit too early for me to absorb. My eyes are still partially closed and I think my brain is still on my pillow.....
ReplyDeleteCam, from what did stay in my head, you are on your way! But...what will you be doing? Specifically, if I may inquire.
Wow, what a business. I can't imagine you being involved in the boring part, though. There's got to be some kind of people/interactive/creative thing going on there.
ReplyDeleteCAM!!!!! WOW!! I am so excited for you.... well the boring blog above not so excited about it sounds rather... technical and well, you know what happens to me in that instance...glazed over eyes... start to day dream... but in this I was DAY DREAMING about TOKYO! What an exciting time, of change for you! I fell in LOVE with Tokyo when we were there, you will enjoy this new place and I know you, you will embrace it.
ReplyDeleteI am glad you found a job in an industry that is not going anywhere... and you will do well, make a wonderful living and life! YAY!!! YAY!!! YAY!!!
At least in Tokyo you can drag your laptop out to someplace and pick up an Internet cafe.. and a Starbucks Americano since there is one on every corner that I can remember!
Update us more when you can... also I was walking the other day and thought of something interesting.... I wanted to share with you when you have time and are settled.
Oh AND.... your close to Matt.... so he and you can prowl the town.... what a COOL thing to happen to you Cam.. I am a little jealous! I want to live in Tokyo!
ReplyDeleteYep. Sewing our Superhero spandex costumes even as we speak.
ReplyDeleteHA Matt... Can you sew one for me too?? LOL
ReplyDeleteMatt... make Cam's black... he looks good in black! hee...
ReplyDeleteI think he's doing translation type help in two different capacities.
In one he helps with publishing of material and consulting for the company as a whole (is that sorta right, Mou?).
And in the other he is like a help desk for employees of the company who need a bi-lingual expert such as he to help them with their problems and issues of Japanese/ English translations.
I think i got that sorta right. From what i remember of his description he gave when he told me about the big move back in Winnipeg.
I was sworn to secrecy... i'm good... ain't i?
I too would love to spend time in the big city. I miss New York living sometimes.
I think the transition will be weird for our country boy, but you know Cam...
He makes things happen!
Well I think you'll be getting unique insight into pharmaceutical companies this way... I hope you learn more than just some technical jargon! Here's to making a difference, having great friends, and finding your new life satisfying and fulfilling in Tokyo!
ReplyDeleteI can't even seem to access Yahoo Mail from the office computer! It won't load!!! So that means I can't check my mail at home, and I can't check it here at the office. Grrr......
ReplyDeleteEditing work, education work, helping with language, and other boring stuff like that. Eventually I imagine I'll be going to meetings with foreign customers, interpreting, and maybe even being a guide dog overseas. Who knows?
All I know now is that wearing socks and shoes all day, every day, SUCKS!
I love you!
I hate that I have no net access at home!!!!!!!
Matt - Please add some purple and pink for our Euro royal roots, and our Japanese royal roots, will you? (My leg length is 37". I hope the crotch doesn't end at my knees).
ReplyDeleteBTW, let's get together!
And Paula, please write my keitai email; I can't get access to anything else, OK?
Jen, I LOVE YOU!
Tell the world what I'm doing here, please.
And why am I ONLINE now on the Multiply chat? Help me turn this damn thing off!!!
Under account settings you can just turn the whole chat thing off. I did, and it's everything I dreamed it would be.
ReplyDeletewhy aren't you working?
ReplyDeleteSlacker.
Me? Today is my day off. Just got back from my jiu-jitsu class. Best class yet! I managed to flip a guy and I almmoooooost had my first choke.
ReplyDeleteNot you, Matthew.
ReplyDeleteI meant the slacker who was writing from work.
Maybe he got busted... hee.
Cool, although I'm a bit disturbed that you're living in a 1LDK. How am I supposed to visit you?
ReplyDeleteFortunately your job gives you a chance to make it up to me; just send any leftover drugs from your clinical trials to the usual address.....
LMAO @ Rob!
ReplyDeleteHe's made plans for visitors, Rob...
He said Mayu gave him her folding bed for his living room...
You need to go see him and check up on him for us.
Thank you, Jenadamo for translating Cam's blog. It does sound like an interesting job. Good luck to you, Cam.
ReplyDeleteSo does this mean you are sort of a .... drug dealer? LOL
ReplyDelete