Our experience in working with regulatory authorities in the health care environment include:

• Establishment of a centralized center tasked with: (1) Receiving, sorting, tracking, and performing data entry of all Adverse Event Reports (AERs), (2) Coding of AERs using MedDRA, and (3) Assuring quality by reviewing manufacturer-submitted MedDRA codes for the FDA's Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER).

• Operation, Management, Maintenance and Enhancement of FDA's Adverse Event Reporting System.

• Clinical trials monitoring, information database management, and document management for the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP).

• Provide Investigational New Drug Application (IND) support, pre-licensing and licensing support, technological support involving programming and analysis, and handle information requests for the Center for Biologics Evaluation and Research (CBER).