Having a problem
with your clinical trials ?
GCP
Solutions can provide assistance in resolving GCP
compliance problems and getting your study back on track
before FDA comes to conduct their pre-approval audit. If
you have not taken advantage of preventive solutions
available to you, I can provide assistance in responding
to the Form FDA 483 and Warning Letter issues and help
you develop corrective actions that will prevent
compliance problems in the future. Not understanding the
inter-dependence of IRB, Sponsor and Investigator GCP
responsibilities may result in unnecessary expense and
paperwork. There are some simple compliance solutions.
How do I know? I conducted clinical study audits for FDA
for 10 years in both the US and Europe. I trained and
supervised other FDA auditors. If I can't help you, I
have contacts within other consulting companies who can
address your problems.
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