Infectious Disease

//Infectious Disease

Leading an Early-Stage Vaccine Study

Dose-ranging, Randomized, Double-blind, Placebo-controlled, Comparative, Parallel Group Vaccine Study
Client: Pharmaceutical company

Client/study focus and needs: We provided project management, protocol/materials review, monitoring, serious adverse event reporting, site management, and site contract management for a multi-site study to conduct an early safety and tolerability clinical trial. We were responsible for the contracts and management of external vendors,

Tracking Adverse Drug Events

Data Management of Mandatory Adverse Event Reporting for Peramivir Emergency Use Authorization
Client: U.S. Food and Drug Administration (FDA)

Client/study focus and needs: We provided adverse event data management services in support of the Peramivir Adverse Event Data Management Program (PAEDMP). We established an adverse event database; conducted the receipt, tracking, and data entry of adverse event

Testing Radiation Diagnosis System

Biodosimetry After Radiological and Nuclear Events – Demographic Study
Client: Industry Partner/Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services

Client/study focus and needs: The clients’ goal was to perform a regulatory compliant clinical study with 250 participants to advance the development of a high-throughput biodosimetry diagnostic system that would provide the