Conduct GCP(1) Audits of CROs and SponsorsConsulting Services


Advantages of Hiring FDASmart

Class We Developed So Others Can Learn From FDASmart Experience (2)

Conduct audits related to compliance (see the specifics in #1 above)

Sponsors hire us to investigate the CROs they have hired or are thinking about hiring

CROs hire us to conduct mock audits, i.e., conduct an audit as if We were sponsor (i.e., a potential customer) and write a gap analysis report

Because We have over 10 years of experience doing industrial strength software development, We audit from two perspectives: (1) as a GCP compliance expert and (2) as an expert in software development. We can evaluate the quality and completeness of any work related to information technology.

Because most auditors do not have an IT background they only evaluate compliance.

“Auditing Information Systems: Are You and Your Vendors Meeting FDA Compliance Expectations?”

(1) GCP – Good Clinical Practice

(2) Contact us and the table of contents from any class can be emailed to you