Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​HI,
I work for a small company and am developing SOPs for company-sponsored clinical trials.  Can someone recommend a vendor where I can purchase these.  I don't wish to reinvent the wheel, by writing from scratch.  I've seen templates online, but mainly for investigator sponsored studies, but I am looking for more than templates and need SOPs tailored for company sponsored clinical studies. Does anyone know who from or where I could obtain or purchase drafts of SOPs, which then can be tailored fairly easily? e.g. Reporting of SAEs/SUSARs, Obtaining Informed Consent from subjects, etc.

Thanks

I might have a few suggestions for you. Feel free to contact me for that personally (not anonymously), if you are interested. Yet, I do not know if my suggested contacts would be willing to sell what they have in this area. I feel one or two might ... With kindest regards,

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Ary Saaman
Director, Regulatory Affairs
Debiotech S.A.
Lausanne
Switzerland
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Original Message:
Sent: 27-Sep-2017 13:42
From: Anonymous Member
Subject: Standard Operating Procedures

This message was posted by a user wishing to remain anonymous

​​HI,
I work for a small company and am developing SOPs for company-sponsored clinical trials.  Can someone recommend a vendor where I can purchase these.  I don't wish to reinvent the wheel, by writing from scratch.  I've seen templates online, but mainly for investigator sponsored studies, but I am looking for more than templates and need SOPs tailored for company sponsored clinical studies. Does anyone know who from or where I could obtain or purchase drafts of SOPs, which then can be tailored fairly easily? e.g. Reporting of SAEs/SUSARs, Obtaining Informed Consent from subjects, etc.

Thanks