FDA has issued a combined synopsis/ solicitation related to FDA/NCTR/Division of Bioinformatics and Biostatistics (DBB) which is conducting research that supports NCTR Research Support Program Acquisition Strategy. The Division of Bioinformatics and Biostatistics (DBB) requires use of the large electronic medical record (EMR) system to conduct research to assess the safety and surveillance of FDA regulated products through the FDA adverse event reporting systems, with the pilot study working on the FDA Adverse Events Reporting System (FAERS) (CDER) database.
A novel data mining and data visualization method will be developed and evaluated by using a large electronic medical record (EMR) system, such as VA databases, for drug induced cardiovascular abnormalities (i.e high blood pressure, stroke, QT prolongation, and arrhythmia) after drug exposure…”
“…The VA Cardio-related database (using drug-induced cardiovascular disease as a starting point) will be developed and used for this contract. The database will be developed using the VA Informatics and Computing Infrastructure (VINCI) database of the VA health system, including…”
Responses are due by May 14, 2018.
