Clinevo Technologies | Clinical Research & Healthcare Technology Solutions

  Ask ten pharmacovigilance (PV) teams to show you the exact Boolean search string used last week to monitor their flagship product, and most will struggle to produce it. They can produce the screening log, the case decisions, even the final ICSRs , but the literal query string, with all its operators, indexed terms, and database-specific syntax, often lives in someone’s PubMed account or a saved Embase session that no auditor can reproduce on demand. This is the gap that turns an otherwise sound PV program into an inspection finding. The search string is not just a technical artefact. It is the foundation on which every downstream decision rests, and regulators have started treating it that way. Why the Search String Is a Regulated Artifact, Not a Tool Setting Under EMA’s Good Pharmacovigilance Practices Module VI, marketing authorisation holders are required to monitor scientific and medical literature systematically, at a minimum on a weekly cadence, using widely indexed databa...

 The pharmaceutical industry is experiencing rapid growth in safety data volumes, making manual pharmacovigilance operations increasingly difficult to manage. E2B(R3) provides a standardized framework for electronic safety report exchange between organizations and regulatory authorities such as the FDA. However, many companies still struggle with: Manual case processing Reporting delays Compliance challenges Fragmented workflows AI-powered pharmacovigilance solutions help organizations modernize safety operations by improving reporting accuracy, automating workflows, and strengthening regulatory readiness. As global compliance expectations continue evolving, intelligent automation is becoming essential for scalable drug safety operations. READ FULL ARTICLE

  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 regula...

  For pharmacovigilance teams in the United States, the FDA  Adverse Event Reporting System  (FAERS) is the most familiar starting point for post-marketing safety surveillance. It is large, regulator-maintained, freely accessible through a public dashboard, and structured around the same ICH E2B(R3) framework that safety teams already use daily. None of that is in dispute. What is increasingly in dispute is the quiet assumption that runs underneath many signal detection programs: that mining FAERS – on its own – is enough. It is not. And the gap between what FAERS reliably surfaces and what is actually happening to patients in the real world has been widening for years. Underreporting, structural reporting biases, missing denominators, latency in spontaneous data, and entire categories of safety information that simply never arrive in FAERS combine to create what is best described as a structural blind spot. Drug safety teams that anchor their entire signal detection meth...