Objective
Assist the Office of Biostatistics (OB), within the Center for Drug
Evaluation and Research (CDER), with statistical programming and
analysis support.
Scope
Identify any potential systemic gender differences in enrollment, safety
and efficacy by conducting meta-analysis across clinical trials.
Objective
In collaboration with CDER, TConneX uses NLP (Nature Language Processing) tool for the extraction, collection, storage, retrieval, analysis, and interpretation of regulatory science data from an array of CDER generated documents, and to archive or index the data using available standard dictionaries, nomenclature, and ontologies.
Objective
TConneX is developing a software tool capable of quantitative data mining of NLM MEDLINE literature database which contains 27 million medical citations to detect novel drug-adverse event (ADE) safety signals. This tool enables FDA to uniformly and systematically harness and analyze the information contained in published literature reports in a standardized manner to support drug safety surveillance and facilitate the performance of pharmacovigilance.
Objective
To provide services for application and database upgrades, and maintenance of the current deployment of Empirica Study/WebSDM software (application and database) in all three environments (test/training, production, development).