Inside Clinevo Case Intake: One Platform for Every Adverse Event Source

 The first hour of a pharmacovigilance team’s day rarely involves a single, clean stream of cases. It involves audio files from a Medical Information Call Center (MICC) line, scanned MedWatch and CIOMS forms attached to emails, structured submissions from affiliate partners, alerts from a patient support program, literature hits forwarded by the surveillance team, and direct submissions through a consumer portal. Every one of these inputs is a potential Individual Case Safety Report (ICSR). Every one of them carries a regulatory clock the moment it is received.



The volume behind that queue is not slowing down. The European Medicines Agency’s 2025 Annual Report on EudraVigilance shows that 1,765,581 ICSRs were collected and managed in EudraVigilance during 2025 alone, bringing the cumulative database to more than 31.2 million ICSRs covering nearly 17.9 million unique cases. FAERS sits at a similar scale on the US side. And these numbers describe only the cases that reach a regulator. The intake, deduplication, and assessment work that happens inside marketing authorisation holders before any submission is several times large

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