Author Topic: Is there any diff.between a CRA frm sponsor and a CRO?  (Read 4211 times)

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Offline Jacob

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Dear all
Do u find any difference between a CRA from a sponsor and a CRO.??? if so [plz explain it :o :o
Jacob :)

Offline drnitinnagrecha

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As such there is no difference between CRA from a sponsor and CRA from a CRO.


First thing to look for is that which SOP's are supposed to be used while monitoring a study on behalf of a sponsor. There are protocol specific sponsor SOP's as well as working SOP's which can be utilized of CRO

Maintaining the right balance between the sponsor SOP and CRO  SOP monitoring has to be done so that no deviation occurs.

DR NiTiN.

Offline ilikecdm

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Right in the beginning of the project, it self it is decided that which SOPs are to be used. Depending on the SOPs to be used, the project specific guidelines are generated and used by the team members.

I Like CDM :)
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Offline pratusha

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Hi,
yes, there is a difference between a CRA in Pharma company and a CRA in a CRO.
the difference is in job profile.

Pratu

Offline ilikecdm

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Please share what exactly is the job description difference?

Offline jaic chacko

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Hi TATA
please add on the job profile difference of a Clinical QA Auditor in an R & D of a pharma company and in a CRO
Regards
Jaic Chacko
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Offline PCR

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Dear all,

Now scenario is changing slightly and what I have seen like few sponsors has taken the initiative and they developed their own Clinical Research team with SOPs and all for conduct of the trials. So if you are talking about the CRA for such sponsor then the job profile is same as what we used to do from Site Selection to Site close out, all the activities we need to perform as a CRA on behalf of Sponsor.

If you are talking about the Collaborative study with CRO & Sponsor then generally what a Sponsor's CRA used to do is he will be the link between a Sponsor and CRO. So he will check the reports and all on behalf of sponsor, he will manage the shipments and study supplies requested by a Site CRA from Sponsor's end then he will come for the initiation visit to check weather all important aspect of the study is been explained or not.

So his task is basically to act of oversee a Site CRA's work and check weather the study is been conducted properly or not and he will report to the Senior management of sponsor about the study progress.

Offline prasanth_i

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Only few of the pharma companies have their own clinical project management & operations management in-house in this case the roles and responsibilities of CRA is same as of CRO
when the trial is contracted to a CRO at that case sponsor -CRA  he/she joins with the CRO CRA for co monitoring for some sites, helps the CRO CRA, and also monitor his/her own.
the roles and responsibilities is same..
Prasanth

Offline srikanth

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HI Folks,

I still don't understand why should there be two Monitors (Sponsor monitor + CRA from a CRO)

Is it not duplicating a role, Is the sponsor very skeptical about the quality offered by the CRO? :-\ :-\

regards
srikanth

Offline llojha

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Hi folks ,

There is no difference between CRA from Pharma Co. & from CRO. The concept of CRA's roles & its responsibilities remains same.

Regards
llojha

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