Posts

Pharmacovigilance (PV) Software Buyer’s Guide 2026

Image
  The pharmacovigilance software market was valued at approximately USD 2.09 billion in 2025 and is projected to reach USD 5.06 billion by 2035, growing at a CAGR of 9.24%. That growth reflects a genuine operational shift, not a commercial trend. Regulatory reporting obligations have expanded across every major jurisdiction. Case volumes have grown steadily. And the expectation that safety teams will process and submit high-quality ICSRs within tight timeframes has become firmly established across the FDA, EMA, PMDA, and MHRA. The decision to invest in PV software is, therefore, rarely about whether to act. It is about which platform to select, how to evaluate it against your organization’s operational reality, and how to avoid the implementation pitfalls that can derail even well-planned programs. This guide is written for decision-makers actively evaluating pharmacovigilance software platforms in 2026, and who need a structured way to separate vendor marketing from operational ...
Post a Comment
Read more

Migrating Your Safety Database: What Nobody Tells You Before You Start

Image
 The common perception of pharmacovigilance database migration is simple: move data from the legacy system, validate it during a transition phase, and deploy it into the new platform. Project timelines are typically estimated at three to six months, depending on portfolio size and complexity. However, organizations often discover that managing historical ICSR data introduces operational and compliance challenges that significantly increase effort beyond the initial plan. READ MORE
Post a Comment
Read more

Duplicate Literature Records in PV: The Compliance Risk No One Talks About, Until Inspection

Image
  Most pharmacovigilance (PV) teams treat duplicate literature records as an operational nuisance. A few cases get merged, a few line listings get cleaned up, and the case backlog moves forward. The problem is that this view holds only until an inspector starts asking why the same patient case appears as three separate ICSRs in your safety database, or why your signal counts for a specific product look inflated against EudraVigilance reference data. At that point, duplicate literature records stop being a housekeeping issue and become a data integrity finding. The European Medicines Agency itself acknowledges the scale of the problem. Its Medical Literature Monitoring (MLM) service was created specifically to “avoid duplication of effort by marketing authorisation holders” and to “prevent the same reports being entered into databases by multiple marketing authorisation holders” for substances with many authorisations across the EEA. When a regulator builds an entire centralised s...
Post a Comment
Read more

How to Build a Compliant Literature Search String for Pharmacovigilance: Why Most Teams Get It Wrong

Image
  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...
Post a Comment
Read more

How AI is Improving E2B(R3) Safety Reporting Workflows

Image
 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
Post a Comment
Read more

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

Image
  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...
Post a Comment
Read more

Why Mining FAERS Alone Is a Signal Detection Blind Spot

Image
  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...
Post a Comment
Read more