CCSA Pharmacovigilance
CCSA provides safety monitoring for both government and private clients. Our experience includes reviewing, QA, coding, and database abstraction of adverse event (AE) and serious adverse event (SAE) data from numerous US and international single- and multisite clinical studies. We routinely perform query identification and resolution, and generate standard and ad hoc reports for IND annual reports, Data Safety Management Board (DSMB) meetings, and study sponsors. We have experience in development of a web-based safety data reporting system, and in transitioning from paper-based to electronic data management systems. We maintain a 24/7 communication line to receive, track, review, and assess SAE reports; perform event coding and database abstraction; identify potential expedited reports; and prepare and submit IND safety reports (7- and 15-day). We have coordinated this effort among clients, study, sponsors, investigators, and other contract research organizations (CROs).
CCSA provides safety monitoring for both government and private clients. Our experience includes reviewing, QA, coding, and database abstraction of adverse event (AE) and serious adverse event (SAE) data from numerous US and international single- and multisite clinical studies. We routinely perform query identification and resolution, and generate standard and ad hoc reports for IND annual reports, Data Safety Management Board (DSMB) meetings, and study sponsors. We have experience in development of a web-based safety data reporting system, and in transitioning from paper-based to electronic data management systems. We maintain a 24/7 communication line to receive, track, review, and assess SAE reports; perform event coding and database abstraction; identify potential expedited reports; and prepare and submit IND safety reports (7- and 15-day). We have coordinated this effort among clients, study, sponsors, investigators, and other contract research organizations (CROs).