The CROs [Clinical Research Organization AKA Contract Research Organization] aren’t visible. They’re a mixture of Consultant/Contract Units so they don’t show unless you know how to look for them. For example, Parexel has been all over these posts I’ve been writing about Seroquel, but I didn’t know it when I was writing them [because I didn’t know what a CRO was]. This post goes back over those posts for a look at the CRO‘s footprints:

Clinical Research Trials

^{Accepted for publication November 6, 1996. This study was supported by a grant from Zeneca Pharmaceuticals, Macclesfield, England, and Wilmington, Del. We thank Suzanne Bristow-Marcalus for medical writing support; Jean Fennimore, RN, and Alison Smith, MSc, for trial organization and management support; Gary Cooper, MS, Jacqueline Fiore, Lesley Farrow, and Barney Home for trial monitoring support; and Kathleen Jelliffe, Denise Redkar-Brown, Joy Russo, and Thais Womack for data management support.}

PAREXEL International Selected as Preferred Provider by AstraZeneca
^{PAREXEL chosen to provide clinical trials development services to international pharmaceutical client}
Goliath
Feb 6, 2002

^{PAREXEL International Corporation, one of the world’s largest biopharmaceutical outsourcing companies, today announced that it has entered into a long-term preferred provider position for global clinical trials development and management services with AstraZeneca International, one of the world’s leading pharmaceutical companies. PAREXEL was awarded the status of Preferred Provider following an in-depth evaluation of its therapeutic expertise, worldwide operations, and knowledgeable experts. This alliance gives AstraZeneca access to PAREXEL’s comprehensive portfolio of biopharmaceutical services, spanning pre-clinical through regulatory approval as well as marketing, medical education, web-based technology solutions and process improvement…}

 

Documents: Analysis and Writing

^{The authors would like to acknowledge the editorial assistance of Aruna Seth, PhD [PAREXEL MMS]. Financial support for this assistance was provided by AstraZeneca Pharmaceuticals LP.}

 

Promoting the Brand

 

KOL [Key Opinion Leader]
MSL [Medical Science Liason]

This post was just meant to show by example what the CROs do – and one of those things is ghostwrite their Clinical Trials. I have no doubt about that. They also do promotion, and write the abstracts and posters used in that enterprise. I suspect that they coordinate and script the KOL activities, but I couldn’t find direct evidence for that activity in the Seroquel unsealed documents. But there are other things that are less tangible. Like this data from a previous post [selling seroquel VII: indication sprawl…]:

Parexel signed on with AstraZeneca in 2002. Looking at the Table of Clinical Trials, it looks as if they got right to work [generating more Clinical Trials business for themselves and indication approvals for AstraZeneca]. That in turn generated launch campaigns and brand promotions for Parexel – quite a marriage. They had some rough going when it turned out that one of AstraZeneca‘s big-mojo Docs [Wayne MacFadden] was having an affair with one of Parexel‘s big mojo writers, and was pumping her for info about a competitor who was also doing business with Parexel. Such things.

I don’t know if Parexel is still doing AstraZeneca‘s Clinical Trials, but somebody is [for Seroquel XR], and this is the most recent one in clinicaltrials.gov – something we’ll talk about later – "globalization."

I apologize for the disjointedness of this post. I wanted to go through this specific example where we have the most inside information to see what the CROs actually do in practice. I expect I missed many clues, but I found enough to let me know that they do a lot. They keep a low profile. There’s apparently no requirement that their presence be specifically acknowledged except as "writing assistance."