Human Medicines
Screened for an adverse event, a suspect product, human data, causality, concomitant medication, country and report type.
Literature Screening
Literature Screening for Pharmacovigilance
Vigintake runs your searches against PubMed every night, screens each new article for your products and records a decision with its reason. Your reviewer confirms it, and included articles move on to case processing.
VigintakeLiterature
PubMedSearch termsHuman medicinesVeterinary productsMedical devicesCosmeticsThe Challenge
Why Literature Screening Takes So Long
GVP Module VI requires MAHs to screen the worldwide literature and local journals at least weekly. The work is repetitive, and every decision has to be documented.
- 01
Volume
A weekly search for a broad portfolio returns hundreds of articles, and most of them contain nothing reportable.
- 02
Mixed Portfolios
Veterinary, device and cosmetic products need their own screening criteria. A checklist written for medicines misses what matters for them.
- 03
Documenting Every Decision
Inspectors and sponsors ask why an article was dismissed. A tick in a spreadsheet does not answer that.
Sources
PubMed, Searched Every Night
Search terms are set per product and per client. New articles are collected every night, deduplicated and queued for screening, with the search that found them recorded.
Literature screening is covered by the GAMP 5 validation package, like the rest of Vigintake.
PubMedMEDLINE and PubMed citations
- Search terms per product and per client
- Searches run every night
- Duplicate PMIDs handled per organisation
- Review date recorded for every article
- Export to XLSX, CSV or PDF for your PV file
- Audit log of every decision
Product Domains
Human, Veterinary, Device and Cosmetic Products
Each domain has its own screening criteria, so a veterinary article is read for species and a cosmetics article for undesirable effects, not against a checklist written for medicines.
Veterinary Products
Target and non-target species are told apart, and species and breed are coded where the article reports them.
Medical Devices
Articles are screened for incidents and adverse events linked to the device, with the device named as it appears in the text.
Cosmetics
Undesirable effects are identified and separated into serious and non-serious, as the EU Cosmetics Regulation requires.
Decisions
A Documented Reason for Every Article
Inspectors ask why an article was dismissed. Vigintake records the decision, the reason and the path through your triage tree for every article, and keeps the reviewer’s final decision with it.
Include, Dismiss or Manual Review
Every article gets one of three decisions. Uncertain articles go to manual review; they are not dismissed.
The Reason, in Your Own Terms
Each decision follows your organisation’s triage tree and records the path it took, for example a different product, a non-corresponding route or presentation, or a country where the product is not marketed.
Ready for the Reviewer
Labels and a suggested comment are prefilled for the reviewer, who confirms or changes the decision. The final decision is the reviewer’s and is recorded as such.
How It Works
From Search to Decision
Four steps, run every night. Every article that is screened leaves a record, whether it is included or not.
- 01
Search
Your search terms run against PubMed every night, per product and per client.
- 02
Screen
Each new article is read against the criteria for its product domain: human, veterinary, medical device or cosmetic.
- 03
Decide
The article is marked include, dismiss or manual review, with the reason and the path through your triage tree.
- 04
Review and Report
The reviewer confirms each decision. Included articles move on to case processing, and the full record exports for your PV system master file.
Who It's for
Who Uses It
PV Service Providers and CROs
Run literature screening for several clients, each with its own search terms, triage tree and reports.
- Search terms and triage tree per client
- Client data separated at the database layer
- Reports per client and per period
- Audit log for sponsor audits
Marketing Authorisation Holders
Screen global and local literature for your whole portfolio, including veterinary, device and cosmetic products, with a documented reason for every decision.
- Human, veterinary, device and cosmetic products
- A recorded reason for every dismissal
- Exports for the PV system master file
- Validated system with a GAMP 5 package
Get Started
Try It on Your Own Products
Book a 30-Minute Call ↗Give us a product and a search term. We will show you last week’s articles screened, with the decision and reason for each one.