Unexpected study problems? 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, assistance can be provided 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. As an FDA Supervisor, I conducted clinical study audits for 10 years in both the US and Europe. As the New Jersey Bioresearch Program Manager, I trained and supervised other FDA auditors. If you need help that I can't provide, I have contacts within other consulting companies who can address your problems. |
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