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After reading some of the posts about getting started as a statistical consultant it made me wonder about the different issues one needs to consider when working on your own.  One issue that has come up on occassions are SOPs and Training.  My small consulting firm has two sets of SOPs - one for clinical stat support and another for laboratory stat support which were requested by some of my clients.  My company has also had a few onsite inspections to review our SOPs, training records and comuter sustems.  I usually have one every other year or so.

My question - is this typical or do most stat consultants get away without having SOPs, training records or inspections?

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Rocco Brunelle
Senior Statistician
Bowsher Brunelle Smith LLC
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  More details are needed. Are you consulting with Pharma or other industries?
 Are you a full service CRO?  Were you audited by the client or FDA or another regulatory agency?



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Chris Barker, Ph.D.
President - San Francisco Bay Area Chapter of the American Statistical Association
www,barkerstats.com
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Hi Chris,

I consult primarilly with Pharma, big and small.  We are not a full service CRO, only stat consulting. And finally we have only been audited by our clients.  It sounds like this is not typical.  Oh well.

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Rocco Brunelle
Senior Statistician
Bowsher Brunelle Smith LLC
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Original Message:
Sent: 09-06-2011 21:22
From: Christopher Barker
Subject: SOPs and Training and Inspections


  More details are needed. Are you consulting with Pharma or other industries?
 Are you a full service CRO?  Were you audited by the client or FDA or another regulatory agency?



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Chris Barker, Ph.D.
President - San Francisco Bay Area Chapter of the American Statistical Association
www,barkerstats.com
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 on a sample size of N=1, I wouldn't jump to conclusions, yet. :)
 
  Do you work on or off the clients site?  Do you have their phase I- III data on your computer?
 Are  you analyzing reporting a Phase I, II, III to FDA or other agency?

( if any of this is your confidential corp. information, then I'm not asking you to reveal secrets).

 Pharma companies can audit their vendors, its routine when a company signs a contract with a CRO .




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Chris Barker, Ph.D.
President - San Francisco Bay Area Chapter of the American Statistical Association
www,barkerstats.com
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Original Message:
Sent: 09-06-2011 21:31
From: Rocco Brunelle
Subject: SOPs and Training and Inspections

Hi Chris,

I consult primarilly with Pharma, big and small.  We are not a full service CRO, only stat consulting. And finally we have only been audited by our clients.  It sounds like this is not typical.  Oh well.

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Rocco Brunelle
Senior Statistician
Bowsher Brunelle Smith LLC
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I am a private consultant and don't have any staff so no training or SOPs.  I think there are a lot of consultants like me.

I really think statistical consulting takes special skills.  It is not enough to be a good professional statistician.  You need to listen to the client, have a lot of discussion, understand the problem and find practical solutions. Some statisticians call themselves consultants but lack these skills or don't appreciate their importance.

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Michael Chernick
Director of Biostatistical Services
Lankenau Institute for Medical Research
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I agree with that.  I think the other thing you have to have is a genuine interest in your client's problem.  Otherwise it's easy to gravitate toward your favorite methodologies and run a big risk of making a Type 3 error.

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Daniel Jeske
Professor and Chair
University of California Department of Statistics
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Original Message:
Sent: 09-06-2011 21:28
From: Michael Chernick
Subject: SOPs and Training and Inspections

I am a private consultant and don't have any staff so no training or SOPs.  I think there are a lot of consultants like me.

I really think statistical consulting takes special skills.  It is not enough to be a good professional statistician.  You need to listen to the client, have a lot of discussion, understand the problem and find practical solutions. Some statisticians call themselves consultants but lack these skills or don't appreciate their importance.

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Michael Chernick
Director of Biostatistical Services
Lankenau Institute for Medical Research
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This probably depends on type of client.  None of my clients (mostly social scientists, psychologists and MDs doing non-trials work) have ever mentioned any of these things


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Peter Flom
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Hi Rocco:

We consult in the pharma (FDA) world and SOPs and training records are mandated.  I have come to view them as very important business tools/resources, rather than a burden.  Simply writing an SOP (or the work instructions - WIs), can help clarify your thinking.  They are fabulous training tools of course.  Our SOPs also cover other things like the IT infrastructure and vendor selection.

When consulting outside the pharma world the business processes don't change so the SOPs stand (or we write a note to file).  Often the clients are impressed with the order and strucure of having this type of material in place, and this gives them confidence.  We sometimes forget that to many of them it is "data in and answers out" - they really do need to trust that what we say and do is worthwhile.

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Janet McDougall
President
McDougall Scientific Ltd
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Original Message:
Sent: 09-07-2011 05:35
From: Peter Flom
Subject: SOPs and Training and Inspections


This probably depends on type of client.  None of my clients (mostly social scientists, psychologists and MDs doing non-trials work) have ever mentioned any of these things


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Peter Flom
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Hi Janet,

I agree with you 100%.  Some of my smaller customers were very pleased that I had these SOPs in place and some have even asked me to help them put together some SOPs for some of their research efforts.  I also do not look at them as a chore but as documentation and guidance as to how I do my work.  I probably feel this way since I worked in Big Pharma for 30 years and helped put together the SOPs we used in the stat department.

Thanks for your reply - I was starting to feel I was the only one out here with SOPs.  Which might not be all bad but it made me wonder why others did not see the value or were not requested to have SOPs.

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Rocco Brunelle
Senior Statistician
Bowsher Brunelle Smith LLC
-------------------------------------------







Original Message:
Sent: 09-08-2011 11:26
From: Janet McDougall
Subject: SOPs and Training and Inspections

Hi Rocco:

We consult in the pharma (FDA) world and SOPs and training records are mandated.  I have come to view them as very important business tools/resources, rather than a burden.  Simply writing an SOP (or the work instructions - WIs), can help clarify your thinking.  They are fabulous training tools of course.  Our SOPs also cover other things like the IT infrastructure and vendor selection.

When consulting outside the pharma world the business processes don't change so the SOPs stand (or we write a note to file).  Often the clients are impressed with the order and strucure of having this type of material in place, and this gives them confidence.  We sometimes forget that to many of them it is "data in and answers out" - they really do need to trust that what we say and do is worthwhile.

-------------------------------------------
Janet McDougall
President
McDougall Scientific Ltd
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