Intake Management
Adverse events do not only arrive by fax. Vigintake monitors scientific literature, social media, e-commerce platforms, patient support interactions, and internal communications, transforming unstructured signals from any origin into structured, submission-ready ICSR cases.
The Challenge
Patients report adverse experiences in product reviews, social media posts, forum threads, and support calls, not only in structured MedWatch forms. Without systematic monitoring of these sources, meaningful safety signals go undetected and regulatory obligations go unmet.
Traditional pharmacovigilance systems monitor structured channels only. The majority of patient-reported experiences now occur in unstructured digital environments.
Manually screening thousands of social media posts, reviews, and literature articles each week is not operationally sustainable with finite safety team resources.
Regulators expect companies to monitor all sources where product-related adverse events may be reported. Gaps in digital surveillance constitute a compliance risk.
Literature Monitoring
Vigintake connects to the major biomedical literature databases and monitors newly published articles for relevant safety information on a daily basis. Identified case reports and signals are automatically extracted, assessed for reportability, and routed into the case processing workflow.
Global literature monitoring is available now. Local and regional literature sources are in active development and will follow shortly.
Public Digital Sources
Patients and caregivers share their experiences with medicines and medical products across dozens of public platforms. Vigintake systematically monitors these channels, screening content for reportable adverse events and product quality complaints.
Public posts, comments, and threads mentioning medicines or medical products are screened for case-qualifying adverse event language.
Product reviews for OTC medicines, supplements, and medical devices frequently contain adverse event reports, product complaints, and packaging concerns.
Patient reviews of healthcare providers, pharmacies, and medical products often contain first-hand reports of unexpected treatment outcomes.
Condition-specific communities generate rich, detailed patient narratives that frequently contain spontaneous adverse event reports of high clinical value.
Published media containing safety-relevant information about medicinal products may trigger regulatory reporting obligations under GVP guidelines.
Reviews of digital health products and connected device companion applications may contain adverse event reports linked to device malfunction or treatment interaction.
Private Enterprise Sources
Much of the most clinically significant safety information flows through internal systems: support call transcripts, medical information enquiries, and company-managed patient forums. Vigintake integrates directly with these private sources, with no manual export required.
Direct connection to your medical information or safety mailbox. Vigintake automatically screens incoming emails for case-qualifying content and extracts ICSR data without any manual triage.
Patient Support Program calls are transcribed and screened automatically. Vigintake identifies reportable adverse events within call recordings and routes them into the case workflow in near real time.
Company-managed patient or HCP portals, closed community forums, and website contact forms are monitored continuously, ensuring that no reportable communication is missed.
How It Works
Vigintake continuously monitors all connected sources, public and private, around the clock, across all configured languages and geographies.
AI classifies each piece of content against reportability criteria: does it contain a suspect product, an adverse event, an identifiable patient, and a reporter?
Qualifying signals are parsed and all ICSR-relevant fields are extracted: product name, reaction terms, patient details, and reporter information.
Structured cases enter the processing workflow with MedDRA coding, narrative draft, and triage classification ready for medical review and submission.
Who It's For
Managing digital surveillance across multiple clients and product portfolios requires a scalable, configurable platform. Vigintake's multi-tenant architecture allows per-client source configuration, keyword sets, and reporting thresholds.
Comprehensive digital surveillance used to require dedicated teams and enterprise contracts. Vigintake makes it accessible from day one, with pre-configured source monitoring for the most common channels and simple activation for additional sources.
Get Started
See how Vigintake monitors your configured sources and surfaces a reportable adverse event in under 3 minutes, live, using your own product data.