Peer Review

Peer review as it relates to quality assurance is a process of subjecting, for example, a Study Director’s preclinical study report and conclusions (hereafter, the “manuscript or report”) to the scrutiny of others who may also be experts in the field. While this may occur internally at the testing facility as a Standard Operating Procedure, the third-party (external) quality assurance peer review process also aims to make authors (and their management) meet the standards of their discipline and of science in general. Since it is ultimately the client (study sponsor) who will accept and submit the report in their regulatory submission, it behooves them to add this extra layer of “scientific and quality assurance” as reports that contain errors are likely to be regarded with suspicion by scholars and professionals in many fields, including in the regulatory arena.

A rationale for peer review is that it is rare for an individual author or quality assurance auditor to spot every mistake or flaw in a complicated piece of work. This is not because deficiencies represent needles in a haystack, but because in a new and perhaps eclectic intellectual product, an opportunity for improvement may stand out only to someone with special expertise or experience. Showing work to others increases the probability that weaknesses will be identified, and with advice and encouragement, fixed.

The process of peer review is considered critical to establishing a reliable body of research and knowledge. Regulatory agents charged with acting upon a submission can only be expert in a limited area; thus they welcome and rely to some degree on the third-party peer-review process to lend additional credibility to the research. Walker Downey & Associates, Inc. will facilitate a peer review process of preclinical study reports, or other written documents by requesting that a client send advance copies of an author's work or conclusions to our internal scientists and auditors who are experts in the field (known as "referees" or "reviewers"), normally by e-mail. Our evaluations will usually include an explicit recommendation of what to do with the report, or manuscript, often chosen from a menu along the lines of the following:

• to unconditionally accept it,
• to accept it in the event that its authors improve it in certain ways,
• to reject it, but encourage revision and invite resubmission,
• to reject it outright.

During this process, the role of the Walker Downey & Associates, Inc. referees is advisory, and the client is under no formal obligation to accept the opinions of the referees. Please contact us at info@walkerdowneyt.com to discuss how we may improve your written communications.

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