How do you decide which GCP consulting service to use?

As an ex-FDA supervisor who has 10 years experience with FDA clinical study audits, I assure you that you need a consultant with FDA experience.

Who can better explain the internal FDA method of determining what citations to list on the Form FDA-483, the rationale for inclusion of GCP citations in FDA Warning Letters, why some Warning Letter citations are not supported by regulatory requirements and what responses to FDA Form 483s and Warning Letters will more likely be acceptable to FDA?

I continue to be amazed by clinical study site reports of monitor/auditor imposed "GCP requirements" that are not supported by existing regulations and likely unnecessary. There are many, but here is one example. Every clinical study site found seriously deficient by FDA was required to have been monitored for compliance with the investigational plan and applicable regulatory requirements. If the clinical site is not compliant, the sponsor is required by the regulations to fix the problems or stop the site's participation in the study. In theory, FDA should never find a seriously non-compliant study site.

Before spending $1000's of dollars on data integrity audits, data verification audits or GCP audits of multiple study sites, ask me to take a look at your situation; you can then decide what the focus of your audit plan should be. It is easier and less costly to prevent GCP problems from putting your study results in jeopardy. If your study monitors find compliance problems at study sites and need advice, they can email questions to me at the following address. This is a free service provided by GCP Solutions. As always, GCP Solutions' advice should be discussed with the monitor's study manager prior to changing current operating procedures.

Shirley H. Isbill
609-218-0609
GCP Solutions Lawrenceville, NJ
GCPSolutions@verizon.net