Organisations our team has worked with
Prior experience, labelled as such
The organisations on this page are ones that members of our team worked with in earlier roles — as employees, consultants, advisors or founders — before or alongside qointa. They are not presented as clients of qointa BV, and naming them does not imply their endorsement.
What that experience covers, person by person, is set out on Who we are and on the team page.
What the experience covers
- Phase II–IV trial management on the sponsor and CRO side.
- Founding and running an integrated eClinical platform.
- Owning a clinical data integration platform inside a large pharmaceutical company.
- Directing 21 CFR Part 11 remediation and the move from CSV to risk-based CSA.
- Taking a Class I medical device through EU MDR 2017/745 as a manufacturer.
- Holding accountable regulated roles: Qualified Person, PRRC, legal representative.
Where our team worked before and alongside qointa
Prior experience of individual team members — not a list of qointa BV clients.
Abbott, Alcon, Boston Scientific, Johnson & Johnson, MSD (Merck & Co.), Novartis, Novo Nordisk, PC PAL / AMBUCE Rescue Team, Pfizer, Regeneron, Roche, Sanofi, UCB
Companies founded by team members: unithink, SUPRCARE
Stefanini Group is a qointa partner rather than a client — see Our Partners.
From the library
Our regulatory position papers and whitepapers. Three download without an account; a free account opens the rest.
qointa Services brochuresFree
qointa's full service portfolio across quality management, regulatory compliance, software development, contract research, patient engagement and digital transformation.
Download PDF →
Position papersFree
A companion reading from the CRO and site seat — which duties are yours, which are the sponsor’s, and which control belongs to neither of you
Read the summary →
Position papers
Why the device is a monitorable data source — and why its telemetry belongs in the risk-based monitoring plan, not outside it
Read the summary →
All papers in the library →
Talk to a specialist
Bring one device and one protocol — a wearable, a sensor, an app, anything. We will tell you which regulatory perimeters it opens and what it takes to close them.
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