Literature monitoring for Swiss authorisations
External providers run the literature obligation as a documented, reproducible service: defined search strings per product, weekly searches in Embase and Medline plus the Swiss trade press, every hit logged and assessed, an ICSR wherever a Swiss identifiable patient appears, and an archive an inspector can follow.
- Last reviewed:
- Reading time: 3 min
- Reviewed by Swiss Pharmacovigilance
What this service is
A recurring search and triage service, delivered with the evidence rather than only the findings. The deliverable is the reproducible strategy and its execution record, because that is what the obligation actually requires and what an inspection examines.
What you get
- A documented search strategy per product, with the strings justified
- Weekly searches in Embase and Medline, with date, operator and result count
- Swiss trade and professional press screening for the relevant specialties
- A hit log with an assessment of each hit: relevant, not relevant, potential case
- ICSR creation and submission for publications with a Swiss identifiable patient
- A quarterly review of the strategy, with changes recorded
- Relevant hits fed into your signal process and the PSUR literature section
- An audit ready archive of searches, assessments and full texts
How external providers run it
- Define the strategy per product: substance and brand terms, databases, limits.
- Run the search weekly and record the execution metadata.
- Triage every hit against defined criteria, with the reasoning noted.
- Escalate potential cases the same day and create the ICSR with day 0 set correctly.
- Deliver a monthly summary and the quarterly strategy review.
- Archive everything so a search can be reproduced years later.
What external providers need from you
- The product list with substances, brand names and Swiss authorisation numbers
- The therapeutic areas and specialties that matter for the Swiss press screening
- Your licensor's global search output, if one exists, and its scope
- A route for potential cases into your case processing, or provider case service
| Source | Cadence | Output | Retention |
|---|---|---|---|
| Embase | Weekly | Search record and hit log | Archived for the retention period |
| Medline | Weekly | Search record and hit log | Archived for the retention period |
| Swiss trade press | Weekly | Screening record and clippings | Archived for the retention period |
| Congress abstracts | Per congress | Abstract and assessment | Archived for the retention period |
| Licensor global output | Per the SDEA cadence | Provider Swiss assessment of it | Archived for the retention period |
| Ad hoc search on a signal | On request | Search record with the question | Archived with the signal file |
Onboarding
- Week 1: product list received, search strings drafted per product.
- Week 2: strings tested and tuned for recall against known publications.
- Week 2: strategy document signed off, escalation route agreed.
- Week 3: first weekly search runs, first hit log delivered.
Pricing model
Priced per product per year, banded by how noisy the substance is in the literature. Database licence costs are passed through transparently. ICSR creation from a literature hit is charged at the case processing rate, or included if external providers already run your case service.
Frequently asked questions
Why weekly and not monthly?
Because a serious literature case carries a 15 day deadline with day 0 on the day of awareness. A monthly cycle burns most of that window before anyone reads the paper. Weekly leaves room for full text retrieval and assessment.
Do you duplicate provider licensor's global search?
No. External providers review their scope and cover what it misses, in particular the Swiss press and any Swiss specific indexing, and external providers document provider assessment of what they send.
What does literature monitoring cost?
Ask the prospective provider for a written scope, pricing basis and proposed timetable. Fees, availability and response times depend on the provider and must be agreed directly.
Who pays for the database licences?
They are passed through at cost. External providers do not mark them up, and external providers tell you which databases the strategy needs before you commit.
Are external providers still responsible for what a search misses?
You remain accountable, which is why the strategy rather than the hit list is the deliverable. A documented, justified and reproducible strategy is what demonstrates the obligation was met.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.