Individual Case Safety Reports, or ICSRs, are a large part of the safety and pharmacovigilance lifecycle. From reporting product problems, adverse events, and consumer complaints, the information they provide is integral in ensuring the safety of medicinal products. Traditionally, ICSRs were seen as cumbersome, though widely accepted that ICSRs are a necessary tool. Today, organizations can handle these more efficiently with the use of ‘’Smart ICSRs’’ that utilize built-in automation and intelligence.
During a recent Industry Perspectives: The Concept of Smart ICSRs with Soterius, a global leader of drug safety and medical outsourcing services and solutions, participants were asked how case processing will change in the next 5 to 10 years, and what should we expect. Twenty-four percent of respondents indicated they feel that case processing will be needed but would be greatly simplified with the use of technology. “We need to start using technology to handle that entire new bucket of information,” said Suneet Walia of Soterius, a client of ArisGlobal utilizing LifeSphere Multivigilance. “For all aspects of the PV organization, this is really going to impact people not just in case processing, but in looking at aggregate data, signal detection, and even extending over to pharma QIP folks who look at much larger, macro data sources.”
Another poll question asked respondents if their organization is now dealing with larger volumes of data, how have they adapted. Though the poll allowed for multiple responses, an overwhelming majority of respondents, 65%, indicated that they have mainly focused on optimizing their business processes. “These responses reflect how the PV industry is right now. We need productivity so that we can assign more and more cases, track quality, and find out how to engage our partners better,” commented Aman Wasan, ArisGlobal’s VP of Commercial Operations.
Smart ICSRs aren’t just the future, they are here now. ArisGlobal understands how safety in drug development is continuing to evolve. With over 30 years of experience in the Life Sciences industry, ArisGlobal is an innovative leader in Pharmacovigilance and Drug Safety software whose mission is to empower life sciences organizations to deliver breakthroughs. Faster.
LifeSphere MultiVigilance is the only automated, end-to-end safety system built with the industry, for the industry, and developed in partnership with the World’s best life sciences companies. It helps hundreds of pharmacovigilance teams worldwide save time and effort; ensures future-proof compliance and keeps global teams aligned.