Monitoring & RBQM.
On-site, remote and centralised monitoring against your risk plan, orchestrated on ViSA, with senior medical oversight on call. Quality is designed in from the first protocol draft.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Risk-based quality planCritical-to-quality factors identified at design; risk plan calibrated to the study's actual risks.
- On-site, remote & centralisedThe mix that fits the study. Remote SDV where the data allows, on-site where the risk demands.
- Centralised signal review via ViSAData trends, protocol deviations and safety signals surfaced centrally, escalated to the right people fast.
- Medical monitoring & adjudicationSenior medical oversight on eligibility, safety events and clinical judgement calls, on-call to sites and sponsors.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- Risk-based quality plan (ICH E6(R3)-aligned)
- Monitoring plan (on-site / remote / centralised mix)
- ViSA centralised monitoring workspace
- Medical monitoring coverage across the study lifecycle
Central monitoring only works when the data lives in one place. ECS® + ViSA give the monitor a single system of record, with the deviations, queries and safety signals already linked to the participant journey.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
You need a monitoring model that reflects a modern, hybrid study.
- Moment 02
A previous study had quality findings that repeated across sites.
- Moment 03
You want senior medical oversight without moving to a full FSP model.
Often engaged together.
Clinical Trials (interventional, DCT / hybrid)
Interventional and post-market studies run end-to-end, centralised, hybrid or fully virtual.
Learn moreIP & study supplies management
Investigational product and supplies, GMP labelling, IRT, release, chain-of-custody and reconciliation, governed on ECS®; distribution via qualified GDP depots.
Learn moreSafety, vigilance & quality by product class
Safety monitoring and vigilance, pharmacovigilance, materiovigilance, cosmeto- and nutrivigilance applied per product class, with ISO 9001 quality assurance across the study lifecycle.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.