Replies to post #178268 on Avid Bioservices Inc (CDMO)

[biopharm]

To add to the FDA new Guidance...

Clinical Outcome Assessment Qualification Program

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm

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...within the link above and can't trace it back just yet, but I've read where its important for "how a patient feels" during a clinical trial on a drug and I'm not sure how vital this is, but my guess is Peregrine is working along these lines as well and/or patient narratives for other reasons, such as on the site " ..theanswertocancer.org"

One employee profile that stresses this importance:

Sr. Medical Writer
Peregrine Pharmaceuticals
July 2013 – Present (1 year)Tustin, CA

• Draft study Protocols and Synopses, Investigator Brochures, Clinical Study Reports, INDs, Module 2 and Module 5 eCTD documents, Patient Narratives, PIP's, and FDA briefing books and response documents for clinical trial studies
• Critically analyze and translate raw efficacy and safety TLG data for presentation to the clinical team and at clinical meetings
• Draft manuscripts, abstracts, posters, and slide decks for scientific publication and research presentation at clinical meetings/symposia
• Develop an understanding of GCP, ICH, EMEA, and FDA regulations and guidance governing clinical research with investigational products, and be conversant with the conditions being evaluated and available/investigational treatment modalities

http://www.linkedin.com/pub/deshawnt-m-jelani/2b/344/a36

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