Descriptive analysis of a rare and fatal adverse event within the FDA Adverse Event Reporting System (FAERS)
Descriptive analysis of a rare and fatal adverse event within the FDA Adverse Event Reporting System (FAERS)
1 PagesCASE STUDY: DISCOVERY / NONCLINICAL CLINICAL DEVELOPMENT MARKET & LAUNCH PRODUCT MAINTENANCE CLIENT SIZE THERAPEUTIC AREA GEOGRAPHY CLIENT NEED OUR SOLUTION PHARMALEX VALUE TO CLIENT Long-term commitment by our project team that allowed consistency in research and reporting Familiarity with data source and subject matter by project team that included a physician, pharmacist, biologist, and a data analyst Fulfilment of recurring regulatory commitments Presented findings in an annual study report, presentations, and multiple conference posters Generated testable hypotheses on the potential risk factors for this rare and typically fatal AE Retrospectively analyzed electronic records and MedWatch form narratives Developed a novel de-duplication algorithm to identify unique cases Applied
