A robust safety signal detection program is critical to any clinical development program. It is important that sponsors are able to monitor trends across indications and studies in order to act proactively and responsibly to mitigate risks. ACI can help support this aspect through a programmatic approach that highlights these safety signals in an easy-to-review clinical format for a sponsor’s safety team.
This program essentially involves establishment of ACI Data Transfer Agreements from all active study CROs with agreement on a date to receive the data. Upon receipt, ACI Clinical will compile, code and format a safety signal report for the sponsor’s review on an ongoing basis based on sponsor preferences.
We can tailor this program based on the safety surveillance plan already in place. Please contact ACI today to discuss how we can support your safety signal detection efforts.