Emissary - A Contract Research Organization (CRO) accelerating clinical research trials http://www.emissary.com/11-clinical-research-articles/clinical-research-professional Thu, 05 Oct 2017 17:00:29 -0500 Joomla! - Open Source Content Management en-gb smayo@emissary.com (Emissary.com) FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance  In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of Investigator form. A Food and Drug Administration Guidance is non-binding, but it does serve as useful information on how to interpret the agency's regulations. Keep in mind that this is only a draft; with the recent change in administration this draft may never be released as final or it may be significantly modified.

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Focus on Clinical Research Professionals Tue, 24 Feb 2009 11:33:05 -0600
FDA’s Bioresearch Monitoring (BIMO) Inspections http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/59-bimo-inspections-in-2007 http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/59-bimo-inspections-in-2007

BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality and integrity of the data submitted to the agency from regulated clinical trials of investigational drugs, devices, and biologics. Inspections are made both in the U.S. and internationally at clinical investigator sites, institutional review boards (IRBs), and sponsors (e.g., pharmaceutical, medical device, and biologic companies, including monitors and contract research organizations or CR0s working under the sponsor).

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Focus on Clinical Research Professionals Fri, 15 Aug 2008 18:47:29 -0500
The Historical Rise of Pharmaceutical Regulation http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/48-history http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/48-history The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers from drug prescribers and drug dispensers. This was the time of the traveling medicine shows selling dangerous, addictive or just non-sense patent medicines. Today's pharmaceutical companies got their start in the apothecary shops of that time, but still, most drugs were imported from Europe. In fact the U.S was a dumping ground for substandard and contaminated drugs.

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Focus on Clinical Research Professionals Sun, 01 Jan 1995 00:00:00 -0600
A Metric System Primer from a Overly Analytical Clinical Research Professional http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/43-metrics http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/43-metrics  For those of you outside of the clinical research industry that don't understand all of the fancy metric terminology we research industry professionals use in our daily activities, we'll here a list.

10^12 dactyls

10^18 stentials

10^21 piccolos

10^18 minations

10^15 coats

10^12 bulls

10^12 microphones

10^12 pins

10^9 lows

10^9 antics

10^9 questions

10^6 bicycles

10^6 airs

2^10^3 millinaries

2x10^3 mockingbirds

1000 Kowalskis

10 cards

10 decor

10 dence

10 halls with boughs of holly

10 rations

3-1/3 tridents

1 centipede/second

1/2 Soviet press agency

10^-1 mate

10^-2 mentals

10^-5 dollars

10^-6 fish

10^-6 scopes

10^-9 goats

10^-12 boos

10^-15 fatales

10^-15 bismol

10^-18 boys

nano-nano (as in Mork & Mindy)

= 1 teradactyl

= 1 exastential

= 1 gigolo

= 1 examination

= 1 petacoat

= 1 terabull

= 1 megaphone

= 1 terrapin

= 1 gigalow

= 1 gigantic

= 1 gigawhat

= 2 megacycles

= 1 millionaire

= 4 seminaries

= 2 kilo mockingbird

= 1 Kilokowalski ("Killer Kowalski")

= 1 decacard

= 1 hector

= 1 decadence

= decahalls with etc.

= 1 decoration

= 1 decade

= 1 velocipede

= 1 demitasse

= 1 decimate

= 1 centimental

= 1 Millicent

= 1 microfiche

= 1 microscope

= 1 nanogoat

= 1 picoboo

= 1 femtofatale

= 1 fepto bismol

= 1 atto boy

= a prefix designating 10^-18

If you want to know how long it took me to compile all of this, well, it took a microcentury or two or three. That's about 52.5 minutes for all of you analytical Clinical Research Associate types. But, then it probably only took you a nanocentury (3.156 seconds) or so to figure out that I've been working a little too hard lately....!

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Focus on Clinical Research Professionals Wed, 12 Mar 2008 11:40:56 -0500
Latin Abbreviations Ad Nauseam http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/41-abbreviations http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/41-abbreviations In case your Latin is a little rusty, here's a list of abbreviations commonly used in medical charts and prescriptions. These may be useful when monitoring medical charts, or maybe just for impressing your friends. Now, if you could only get training on how to read the awful handwriting...

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Focus on Clinical Research Professionals Wed, 12 Mar 2008 11:38:17 -0500
The Adventures of SuperMonitor http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/35-supermonitor http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/35-supermonitor A Bedtime Story for the Young Clinical Research Associate.

Second only to being a father to my son, the most important and fulfilling job I’ve ever had was being a Clinical Research Associate (CRA). Monitoring a study, like parenting a child, is a tremendous responsibility. When you are a Clinical Research Associate, millions of people — or perhaps that one innocent child — depend on you to ensuring the study integrity, so that only safe and effective products reach the marketplace.

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Focus on Clinical Research Professionals Wed, 12 Mar 2008 11:27:50 -0500
Committed to the Quest http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/34-quest http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/34-quest … or Why I Became a Clinical Research Professional.

 

It all started because of a commitment I made when I was too young to understand into what I was getting myself. My mother had headaches, you see. Not the usual “throbbing-in-the-temples” kind of headaches, but the “gut-wrenching, totally incapacitating, rip-the-carpet-out-with-your-bare-hands” kind of headaches. Migraine, cluster headache, trigeminal neuralgia—whatever the flavor, they were bad. Really bad.

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Focus on Clinical Research Professionals Wed, 12 Mar 2008 11:27:05 -0500
Time Management for the Research Professional http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/33-time-management http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/33-time-management It's been said that a pharmaceutical company loses $1 million for every day of delay during clinical research and development. This is a theoretical cost related to the dramatic reduction in sales when a drug product loses patent protection and becomes subject to generic competition. Nevertheless, the fact remains that, as clinical research professionals, we must be excellent managers, not just of others, but of our own time, as well.

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Focus on Clinical Research Professionals Mon, 01 Jan 1996 10:25:51 -0600
Consulting is an Art http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/32-clinical-research-consulting http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/32-clinical-research-consulting ...or Why I'm Not a Singing CRA.

During those confusing and wondrous years, when a young man ponders his career choices, my dream was to become a singer-songwriter. Blowing my hard-earned profits from an after school job on a multi-track recorder, I spent precious study time mixing down vocal, guitar and synthesizer tracks composing what would surely become the next big platinum album.

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]]> Focus on Clinical Research Professionals Wed, 01 Jul 1998 01:00:00 -0500 Clinical Research Regulation: FDA vs. ICH http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/44-fda-ich http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/44-fda-ich On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90), the latest rendition of the International Conference on Harmonization (ICH) Guideline covering the conduct of clinical research studies in the seven member nations. Guidelines represent the agency's current thinking on Good Clinical Practices, but do not bind the FDA or the public. However, most clinical research studies are now being conducted in compliance with this guideline, especially if the results might be used for an international regulatory submission. Here are the major differences.

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Focus on Clinical Research Professionals Sat, 02 Jan 1999 11:28:50 -0600