CCSA Bioinformatics and Data Management
Government and private-sector clients have employed our database products to achieve drug discovery and development goals. Examples of relational databases developed at CCSA include systems to track and report SAEs to FDA, pharmaceutical partners, and foreign regulatory bodies; products to track protocol receipt, review, FDA submission, and implementation; and study‑specific Oracle‑based per-patient safety and efficacy databases. We develop and maintain databases on nonclinical and clinical testing data relevant to the drug development efforts of our government and other clients. Based on our web-based remote data capture (RDC) systems, clinical data from sponsored trials are extracted, organized, analyzed, reviewed, and reported for regulatory authorities as well as DSMB, Institutional Review Board (IRB), and NIH submissions and publications.
Government and private-sector clients have employed our database products to achieve drug discovery and development goals. Examples of relational databases developed at CCSA include systems to track and report SAEs to FDA, pharmaceutical partners, and foreign regulatory bodies; products to track protocol receipt, review, FDA submission, and implementation; and study‑specific Oracle‑based per-patient safety and efficacy databases. We develop and maintain databases on nonclinical and clinical testing data relevant to the drug development efforts of our government and other clients. Based on our web-based remote data capture (RDC) systems, clinical data from sponsored trials are extracted, organized, analyzed, reviewed, and reported for regulatory authorities as well as DSMB, Institutional Review Board (IRB), and NIH submissions and publications.