Sponsor and vendor. Clinic and boardroom. Regulator-facing and revenue-facing. That is an unusual combination, and it is the reason our assessments hold up.
of team experience in eClinical, medical devices and digital health
50+
clinical trials supported by members of the team, before qointa
30+
countries and 32 languages in programmes team members ran, before qointa
$1B+
later valuation of ArisGlobal in a Nordic Capital transaction — the group a qointa founder's eClinical platform became part of
Most compliance advice comes from people who have never had to ship
The regulatory consultancy market divides neatly into two groups. There are auditors and
quality specialists who know the frameworks cold but have never had to deliver a study on a
deadline. And there are technology vendors who can build anything but treat regulation as
paperwork to be survived.
Neither group is much use when a firmware update lands mid-study and someone has to decide,
that week, whether it is a documentation change or a new validation. That decision needs a
person who understands the standard, the software, the protocol and the commercial cost of
getting it wrong.
qointa was built by people who have held all four positions.
What our people have actually done
Not a capability list. Things that happened.
Managed the trials
Phase II–IV trial management inside large pharma and CRO organisations — Schering-Plough/MSD, Covance/UCB, Byk Gulden, Quintiles. We have been the sponsor-side person who has to make a device decision and live with it.
Built the eClinical platform
Founded one of the first genuinely integrated eClinical platforms — CRF, eCOA, RTSM and compliance on a single database. Grown from zero to €6M order intake in three years and 85 people across three continents in twelve months. Acquired, and became part of ArisGlobal, later valued above $1B in a Nordic Capital transaction.
Owned the platform inside big pharma
One of us owned an AI- and cloud-enabled clinical data integration platform at a top-five pharmaceutical company, with teams across four countries.
Rebuilt validation so it stopped slowing delivery
Directed a worldwide 21 CFR Part 11 remediation, moving from document-heavy CSV to risk-based CSA — without losing compliance. We know the difference between rigour and paperwork.
Ran the largest deployments
Ran large-scale eClinical deployments. We know what breaks at that scale because we were the ones fixing it.
Took a Class I device through EU MDR
Co-founded a smart medical textiles company and took a Class I medical device through EU MDR 2017/745 — in a compressed pandemic timeline.
Practised medicine and ran the science
Our clinical side includes a practising paediatric endocrinologist and diabetologist at a university hospital, a guest professor, and a former president of a national paediatric endocrinology study group responsible for its national registry and multicentre studies.
Held the regulated roles
Qualified Person, legal representative, responsible haematologist, Person Responsible for Regulatory Compliance. Founded and led a laboratory group. These are accountable positions, not advisory ones.
Sat on the investor side
Sourced and supported life sciences and digital health investments across the Nordics and Benelux as a venture representative, and took operating roles inside portfolio companies. We can tell you how your device programme reads to someone doing diligence.
Turned businesses around
Turned around a healthcare software division and closed the largest contract in that division's history. Compliance work that ignores commercial reality does not get implemented.
Every line on this page sits on one side of the table or the other — and the three below sit on both.
Why that mix matters for your trial
A regulatory opinion is only as good as the range of failure it has seen. Ours has been
formed by running the studies, building the systems, certifying the devices, holding the
accountable roles and carrying the P&L. When we tell you a device opens a perimeter, that
judgement is drawn from having been on the receiving end of the consequence.
It also means we are direct. If a device is out of scope, we will say so, and the fee reflects the reduced scope.
If your vendor has quietly made you the manufacturer, we will tell you that too — early, when
it is still cheap to fix.
How we work
Small, senior and embedded. You get the people described above, not a delivery pyramid with
a partner's name on the cover. Every assessment is recorded so that the reasoning survives
staff turnover, at your organisation and at ours.
Judge the thinking, not the biography
The print brochure below is free. These two open with a free account — no approval step, no sales call attached.
