LiveWorld was brought in to help the revamp of adverse event management processes so it more closely matched the practices used in other regions/groups. We reviewed six months of social media back data to identify any missed reportables to ensure compliance.
The implemented LiveWorld adverse event/FDA compliance process included:
- 24x7x365 screening of content by adverse event specialists of content for AEs and escalation and routing in near real time
- A tailored process that would bring all social content into a single system for identification and reporting of adverse events
- Comprehensive storage of processes and methods with timelines, including arrival time, time screened, reporting time, and actions taken by Pharmacovigilance team
- The client was provided with a single social media archive for storage of FDA-compliant source information, such as source location, case and tracking numbers, images, and publishing times
The LiveWorld adverse event specialists worked with the pharma to identify any mention of reactions, efficacy issues, off-label use, product complaints, product quality issues, product questions, and other key issues of interest to the client. Our multi-lingual team was able to monitor social media in numerous languages and dialects in the company’s global regions around the clock.
Once we identified an adverse event, we used our proven process to transfer the critical information to the pharmacovigilance team including providing a case management system to track and then archive for FDA social media compliance.