The people behind qointa.
Senior, small, and personally accountable for the work.
The team
Rudiger Mees — Founder & CEO
Serial entrepreneur and business development executive with 25+ years in eClinical technology, medical devices and digital health. Founded unithink, one of the first integrated eClinical platforms — CRF, eCOA, RTSM and compliance on a single database — growing it from zero to €6M+ order intake in three years and 85 people across Belgium, India and Raleigh NC within twelve months; the business was acquired, became part of ArisGlobal, and Nordic Capital acquired 50% in a transaction valued above $1B. Previously Director Healthcare & Software Solutions at Cegeka, where he closed the largest contract in the division's history. Began in Phase II–IV trial management at Schering-Plough/MSD, Covance/UCB, Byk Gulden and Quintiles. Strategic advisor to Stefanini Group, where he closed a multi-million dollar contract with Evinova, AstraZeneca's digital health venture. Co-founder and CEO of SUPRCARE, which took a Class I medical device through EU MDR 2017/745. Advisor to Snapiot through to its acquisition by Covance (Labcorp) in 2019. European Representative and Executive Director at RQR Advisors, 2020–2025. Person Responsible for Regulatory Compliance at PC PAL / Ambuce Rescue Team.
Kunal Sen-Gupta — Partner & Principal
Twenty-five years across the sponsor, vendor and consulting seats — Merck, Pfizer, Apotex, Novo Nordisk, Sanofi, Regeneron and Roche — and Head of Quality for the unithink eClinical SaaS platform. At Roche, owned end-to-end strategy and delivery of an AI- and cloud-enabled clinical data integration platform harmonising data across 100+ concurrent global studies, accountable for the product roadmap, GxP regulatory strategy, FDA/EMA/HIPAA/GDPR compliance and an annual budget of CHF 8M+, with teams across the US, UK, Poland and Switzerland. Built quality organisations and compliance shared-services centres from the ground up across the US, Europe and India; directed a worldwide 21 CFR Part 11 remediation programme at Novo Nordisk, cutting annual operating costs 38% through standardisation. Moved from document-heavy CSV to risk-based CSA. At unithink, architected an enterprise risk-based quality system embedding compliance into the SDLC, reducing audit findings 70% in year one and a further 20% in year two with a 16-person team across three regions. B.Eng. from NIT India, graduate studies in software engineering at the University of Colorado Boulder, graduate diploma in information systems at the London School of Economics. Certified ITIL Foundation Professional; Masters Certificate in Project Management, Schulich School of Business.
Raoul Rooman, MD PhD — Clinical & Scientific Advisor
Paediatric endocrinologist and diabetologist at Antwerp University Hospital, where he has practised since 1997 and directed the Paediatric Diabetes Center. MD from Antwerp University; doctoral thesis on growth inhibition by steroids and its interaction with the GH–IGF–growth plate axis (2004); degree in dermatocosmetic sciences from the University of Brussels. Research fellow at the University of North Carolina at Chapel Hill, then researcher at the Janssen Research Foundation (Johnson & Johnson) in Beerse. Subspecialty training in paediatric endocrinology and diabetes at the Wilhelmina Children's Hospital, UMC Utrecht. Guest professor at the Faculty of Medicine and Health Sciences, University of Antwerp. Twelve years as secretary and president of the Belgian Study Group for Pediatric Endocrinology, responsible for the national registry and several national and international multicentre studies. Founder of PendoCon, a consultancy in paediatric endocrinology and diabetes focused on clinical trial development and management, patient education and empowerment, and telemedicine.
Marc Jan Waeterschoot — Regulatory & Quality Advisor
Pharmacist and clinical pathologist (State University of Ghent), specialised in haematology, immunology, bacteriology and radiotherapy, with management education at Vlerick. Founder and responsible clinical pathologist of Klinisch Labo Boom and Labo Medicom; CEO European Operations, laboratory division, at Unilabs Holding SA. Founder and CEO of Cryo-Save Group NV (Euronext-listed), Europe's largest cord blood bank with over 250,000 samples stored, operating in more than 40 countries; later President of the Board and interim CEO. Held the accountable regulated roles across the group — Qualified Person, legal representative and responsible haematologist — and served as Qualified Person for the Stichting Tissue Bank. Founder and CEO of The Cell-Factory NV (tissue engineering) and of a pharmaceutical enterprise focused on orphan drugs and generics for leprosy, tuberculosis, malaria and sexually transmitted disease. Project coordinator for University Hospital Antwerp and Gemelli Hospital, Rome.
Read the thinking behind this
Our regulatory position papers and whitepapers. Three download without an account; a free account opens the rest.
BrochuresFree
The qointa brochure
The qointa brochure in print format: what we do, for whom, and how an engagement runs.
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Position papersFree
The Sponsor’s Accountability Map
A companion reading from the sponsor’s seat — what you can delegate the work of, and what you answer for regardless
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Position papers
Inspection-Ready: What FDA, EU and MHRA Inspectors Look For in DHT Evidence
In qointa’s experience the first inspection sets the baseline. What digital-trial evidence inspectors expect, what it is grounded in — and why it must exist before they ask.
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