Safety, vigilance & quality by product class.
Safety monitoring and vigilance applied by product class, pharmacovigilance, materiovigilance, cosmetovigilance and nutrivigilance, with medical oversight on call.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Case intake & processingAdverse event collection, triage, medical review and coding to MedDRA, within the timelines your framework sets.
- Expedited & periodic reportingRegulatory reporting to the competent authorities, plus DSUR/PSUR-class periodic documents.
- Signal detection & risk managementOngoing signal review with risk management measures documented and tracked to closure.
- Vigilance by product classMateriovigilance for devices, cosmetovigilance and nutrivigilance for CHC and nutrition, each to its own framework.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- Safety management plan
- Processed and medically reviewed case files
- Expedited reports and periodic safety documents
- Signal detection log and risk management actions
Safety events raised at any ECS® touchpoint, site, home visit or participant app, land in one safety workflow, so nothing is discovered late in a reconciliation.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
A study is starting and safety reporting obligations need an owner.
- Moment 02
You need vigilance for a product class outside classic pharmacovigilance.
- Moment 03
Post-market surveillance obligations have outgrown the in-house team.
Often engaged together.
Monitoring & RBQM
Quality by design across the whole study, not monitoring alone: risk assessment, on-site, remote and centralised oversight against your risk plan, corrective actions tracked on ViSA.
Learn moreClinical Trials (interventional, DCT / hybrid)
Interventional and post-market studies run end-to-end, centralised, hybrid or fully virtual.
Learn moreRegulatory strategy, submission and market access
Route to approval and route to reimbursement: feasibility, EMA/FDA and MDR/IVDR pathways, submissions, HEOR and payer dossiers.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.