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	<title>Comments on: Trouble For Hire? CRO Oversight Is Lacking</title>
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	<pubDate>Mon, 22 Mar 2010 14:28:33 +0000</pubDate>
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		<title>By: Chris</title>
		<link>http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-304447</link>
		<dc:creator>Chris</dc:creator>
		<pubDate>Tue, 22 Apr 2008 01:29:31 +0000</pubDate>
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		<description>Hello Cranky
I'm not sure what your CRO experience is but I would have thought that sponsoring companies (ie pharma) would have in place reasonable oversight to be sure that their not insignificant investment in a trial would be conducted to a level that allowed its widespread use. In other words, why settle for something half baked (poor quality research) when so much is being spent?

As I read Contrarian's comments they seem to say that CROs operate to the same standards as pharmas, and not whether pharmas apply similar rigorous standards to CROs. in my experience that would be true. Again whether pharma is blase eough to spend all that money without adequate monitoring is another one altogether.

Chris</description>
		<content:encoded><![CDATA[<p>Hello Cranky<br />
I&#8217;m not sure what your CRO experience is but I would have thought that sponsoring companies (ie pharma) would have in place reasonable oversight to be sure that their not insignificant investment in a trial would be conducted to a level that allowed its widespread use. In other words, why settle for something half baked (poor quality research) when so much is being spent?</p>
<p>As I read Contrarian&#8217;s comments they seem to say that CROs operate to the same standards as pharmas, and not whether pharmas apply similar rigorous standards to CROs. in my experience that would be true. Again whether pharma is blase eough to spend all that money without adequate monitoring is another one altogether.</p>
<p>Chris</p>
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		<title>By: ol cranky</title>
		<link>http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-304434</link>
		<dc:creator>ol cranky</dc:creator>
		<pubDate>Tue, 22 Apr 2008 01:18:29 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-304434</guid>
		<description>&lt;blockquote&gt;The legitimate CROs operate according to the same GCPs that pharma does and have rigoruos SOPs in force. They may do much better work than the pharma companies themselves because they don’t have the big conflict of interest and operate with little bias.&lt;/blockquote&gt;

I'm not so sure I can agree with this.  The problem is that sponsor companies, in general, do not provide the necessary oversight of CROs to ensure compliance with either CRO or sponsor SOPs, let alone GCPs.  The quality of the work and trial is dependent on the project managers/directors at both the CRO and the sponsors.  Too often, people at the sponsor company rail against actually managing the CRO by claiming it's duplicating work but, in doing so, they are abrogating their responsibilities.  Without active management of the CRO, they can and will take liberties and lower standards which leads to poor quality research overall.</description>
		<content:encoded><![CDATA[<blockquote><p>The legitimate CROs operate according to the same GCPs that pharma does and have rigoruos SOPs in force. They may do much better work than the pharma companies themselves because they don’t have the big conflict of interest and operate with little bias.</p></blockquote>
<p>I&#8217;m not so sure I can agree with this.  The problem is that sponsor companies, in general, do not provide the necessary oversight of CROs to ensure compliance with either CRO or sponsor SOPs, let alone GCPs.  The quality of the work and trial is dependent on the project managers/directors at both the CRO and the sponsors.  Too often, people at the sponsor company rail against actually managing the CRO by claiming it&#8217;s duplicating work but, in doing so, they are abrogating their responsibilities.  Without active management of the CRO, they can and will take liberties and lower standards which leads to poor quality research overall.</p>
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		<title>By: The Medical Quack: Trouble For Hire? CRO Oversight Is Lacking</title>
		<link>http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-303499</link>
		<dc:creator>The Medical Quack: Trouble For Hire? CRO Oversight Is Lacking</dc:creator>
		<pubDate>Mon, 21 Apr 2008 17:25:49 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-303499</guid>
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		<content:encoded><![CDATA[<p>[...] Pharmalot &#187; Trouble For Hire? CRO Oversight Is Lacking     &#9830;DiggIt! &#9830;Add to del.icio.us &#9830;Add to Technorati Favorites &#9830;Add to Facebook  &#9830;Add to Stumble Upon   SHARETHIS.addEntry({ title:&#8217;Share me&#8217;, summary:&#8217;Sharing is good for the soul.&#8217;, icon: &#8216;http://path.to/icon&#8217; }, {button:true} ); [...]</p>
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		<title>By: Contrarian</title>
		<link>http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-303200</link>
		<dc:creator>Contrarian</dc:creator>
		<pubDate>Mon, 21 Apr 2008 15:52:57 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/trouble-for-hire-cro-oversight-is-lacking/#comment-303200</guid>
		<description>The legitimate CROs operate according to the same GCPs that pharma does and have rigoruos SOPs in force.  They may do much better work than the pharma companies themselves because they don't have the big conflict of interest and operate with little bias.  If the government went into both pharma and CROs with regularity, they may actually be shocked by what they find - many more problems in pharma's closet!</description>
		<content:encoded><![CDATA[<p>The legitimate CROs operate according to the same GCPs that pharma does and have rigoruos SOPs in force.  They may do much better work than the pharma companies themselves because they don&#8217;t have the big conflict of interest and operate with little bias.  If the government went into both pharma and CROs with regularity, they may actually be shocked by what they find - many more problems in pharma&#8217;s closet!</p>
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