Science
Biostatistics and clinical trial / study design support for evidence that must withstand scrutiny.
QData Intelligence
Scientific, software and regulatory support for life-sciences programmes
We help MedTech, digital health, Biotech & Pharma and research organisations connect biostatistics, clinical methodology, medical software engineering and regulatory documentation — so evidence, intended use and documentation stay aligned as programmes move toward EU and US expectations.
Expertise
Three connected capability groups: science, software and regulatory documentation.
Software
Medical and digital health software engineering in regulated contexts — including SaMD support.
Regulatory
Documentation and interaction support related to FDA, EMA and applicable procedures.
Who we help
Organisations we support across industry, healthcare and research.
MedTech
Align engineering, evidence and device documentation before late-stage gaps become expensive.
Biotech & Pharma
Study design, biostatistics and regulatory writing for evidence packages.
Digital Health
Product engineering to medical-software and SaMD rules when intended use points that way.
Research organisations
Methodological and analytical collaboration for institutes and consortia.
Experience
~20years of professional experience
40+organisations collaborated with
Many engagements remain confidential for contractual or legal reasons. Anonymised selected work and a short sector list (no company names) show how we describe programme work.
See selected workHow we work
Five stages — Discover, Frame, Build, Harden, Hand over — keep methodology, intended use and documentation in dialogue.
Read our methodology →Trust
Role boundaries, security capability and documentation discipline for regulated-sector programmes.
Quality, security & trust →Ready to discuss a programme?
Tell us about your organisation and the type of support you need.