Adverse events
PMCF studies and pharmacovigilance
What's included
Adverse events, captured where care happens
Adverse event capture
Patients and clinicians report adverse events in the diary, close to when they happen - not months later in a spreadsheet.
PMCF studies
Post-market clinical follow-up on the schedule in your approved plan: safety, performance, and quality of life in one programme.
Pharmacovigilance (PV)
The same capture for medicinal products. Events are linked to product and pathway and routed for pharmacovigilance review.
Patient and site reports
Patient-reported events and clinician assessments sit on one record, so safety review sees both sides of the same case.
Product-linked safety
Each adverse event is tied to product, batch, indication, and site - ready to filter for PMCF evaluation and PV review.
Audit-ready exports
Who reported what, and when, stays in the audit trail. Aggregated safety summaries export for periodic reports and internal review.
Live safety intelligence
See the safety profile as evidence accumulates
Monitor exposure, adverse events, serious adverse events, follow-up, and review times across products and sites. The illustrative dashboard below shows how a mature 1,924-patient programme could look.
Live safety view
Pharmacovigilance dashboard
Illustrative multi-product cohort
1,924
Patients monitored
Across 38 active sites
24
Adverse events
1.25% of patients
3
Serious adverse events
0.16% of patients
98.6%
Event-free patients
No reported AE or SAE
91.8%
Follow-up complete
All expected safety checks
3.4h
Median review time
Report to safety review
Reports by month
New AE and SAE reports received
Event categories
All products, year to date
Safety signal status: no signal detected
Observed event rates remain below the configured review thresholds.
Built for safety review
PMCF studies and pharmacovigilance both need adverse events that can be traced back to the product and the pathway. We collect them in the same programme as the follow-up.
- ✓Patient-reported adverse events from the diary, in the patient's language
- ✓Clinician-reported events on the same record
- ✓Seriousness, outcome, and relatedness where your plan asks for them
- ✓Product, batch, indication, and site on every event
- ✓Routed to your safety team with a full audit trail
Patient Watch is capture software for adverse events, longitudinal PRO, and configured site forms - not a full safety database or Medidata-style eCRF. That is usually the right fit for PMCF studies and pharmacovigilance capture. Your PV system or CRO still owns case processing where that is required.
PV Case Study
IBSA and Sinovial - outcomes with safety capture
Programme start: May 2026
Patient Watch supports the IBSA and Sinovial multi-centre knee osteoarthritis programme, combining licensed PROMs with structured safety follow-up. Patient reports are linked to product, injection, clinician, and site so the PV team receives usable case context rather than an isolated symptom.
- •Adverse-event checks alongside Oxford Knee Score, EQ-5D and pain follow-up
- •Product, injection date, clinician, site, severity and outcome captured on one record
- •Cohort-level safety summaries for medical, regulatory and pharmacovigilance review
PV Case Study
Anika Therapeutics - governed AE and SAE workflows
Programme start: July 2026
Anika's UK and Germany Cingal programme uses Patient Watch for longitudinal outcomes and post-market safety capture. Potential adverse events move through a governed workflow from patient report to investigator assessment, sponsor classification, and PV review with every decision retained in the audit trail.
- •AE and SAE classification with seriousness, expectedness, relatedness and outcome
- •Configured notifications and escalation to sponsor safety and medical-monitor teams
- •English and German patient journeys with market-level safety dashboards
Case Study
Otivio FlowOx - multi-market MS surveillance
Target go-live: July 2026
Patient Watch is building the digital follow-up layer forFlowOx home therapy inDenmark (Bandasjist) andGermany (OxyCare). Patients completeMSIS-29 plus market-specific tracking -PSFS in Denmark andNRS in Germany - with automated reminders in Danish and German.
- •Baseline and 4-week MSIS-29 milestones, then ongoing monitoring for continuing use
- •QR or invite onboarding, consent, prescription upload and training confirmation before first assessment
- •Clinician caseload views and downloadable progress reports for Bandasjist and German distributor sites
- •Aggregated post-market exports for Otivio across both countries
Ask us about post-market capture for a home-use device with multi-country distributor networks.
Plan your programme with us
Tell us about your product and how you need adverse events captured. We'll scope the follow-up for PMCF studies or pharmacovigilance.