Clinical Trials & eTMF
Trial platforms (eTMF, IRT/IWRS, site management) on Veeva Vault or bespoke, validated end to end.
Industries / Pharma
Pharma engineering that clears FDA
Clinical platforms, pharmacovigilance, eCTD submissions, and discovery AI, shipped by senior teams from inside Tier-1 pharma, CDMOs, and CROs.
0+Pharma & CRO programmes
0%First-pass FDA / EMA inspection
0%Faster study start-up
What we deliver
The whole pharma stack, one pod
Build, validate, and run the full pharma estate under a single accountable senior pod.
EDC & Patient Capture
ePRO and eCOA capture wired into Medidata Rave, Oracle Clinical, and OpenClinica, GCP-validated, audit-trailed.
Pharmacovigilance & Safety
ICSR intake, signal detection, and aggregate reporting, Argus and ArisGlobal, aligned to E2B(R3) and MedDRA.
eCTD Submissions
Auto-publishing eCTD platforms with FDA/EMA gateway integration, IND, NDA, MAA, and BLA, lifecycle-managed.
GxP Data & Lineage
Validated lakes, SDTM/ADaM pipelines, and full lineage, every CSR figure traceable to source.
AI for Drug Discovery
Target ID, generative chemistry, ADMET prediction, and trial AI, with eval harnesses and model-risk packs.
The pharma advantage
Trials Started Faster. Submissions Cleared Sooner.
Every BritonOne Technology pharma programme ships its validation pack, audit trail, and 21 CFR Part 11 evidence alongside the code, not three months after the inspection. The result: 42% faster study start-up, zero FDA Form 483 observations on engineered systems, and submissions that clear EMA on first read.
BritonOne Technology
Before: Traditional Pharma ITValidation packs assembled at inspection
IQ/OQ/PQ scrambled the month before audit, and findings repeat at every inspection cycle.
Trial start-up takes months
Bespoke site builds, paper-heavy training, and manual CRF programming bottleneck every study.
SDTM mapping by hand
Statisticians map raw CRF data to SDTM weeks before lock; errors surface in the CSR review.
Pharmacovigilance backlogs
ICSRs queue for manual coding; aggregate reports miss windows; agencies escalate.
BritonOne Technology
Now: BritonOne Technology-Engineered Pharma21 CFR Part 11 baked in from day one
Audit trails, electronic signatures, and validation evidence emit per release, every build is inspection-ready.
Sites stood up in days
Templated study builds, automated CRF generation, and pre-validated components compress start-up.
Auto-SDTM and define.xml
Mappings live as code, gated in CI, regenerated on every CRF change, lock cycles drop by weeks.
Real-time PV with auto-coding
MedDRA auto-coding, signal detection in-pipeline, and aggregate reports generated on demand.
3×Faster study start-up
42%Lock cycle compressed
100%First-pass agency review
0Form 483 observations
3×Faster study start-up
42%Lock cycle compressed
100%First-pass agency review
0Form 483 observations
Where pharma customers see it pay off
Selected programmes across Tier-1 pharma, speciality, CDMOs, CROs, and emerging biotech, anonymised where required, specific on the outcome.
Tier-1 Pharma52% drafting time saved
Generative AI for medical writing at a top-5 pharma
Production RAG over clinical study reports, regulatory submissions, and target labels, 4,200 medical writers and regulatory affairs colleagues live on the platform. Validation pack and 21 CFR Part 11 audit trail shipped alongside the build; cleared model risk on first review. Document drafting time cut by half across CSR, IB, and protocol templates.
- GenAI medical writing
- Veeva + Azure
- 21 CFR Part 11
Speciality Pharma0 late submissions
Pharmacovigilance modernisation
ICSR intake, MedDRA auto-coding, and signal detection rebuilt, agency windows met without overtime.
- Argus + signal detection
- MedDRA auto-coding
- ICSR pipeline
CRO3 wks to first patient
EDC platform for a global CRO
Templated study builds with auto-CRF generation, site activation in days, not months.
- Medidata Rave
- Auto-CRF generation
- Templated studies
CDMO98% right-first-time
MES + LIMS integration at a contract manufacturer
Bidirectional MES/LIMS wiring with batch-record automation, GMP audit trail captured at every step.
- MES + LIMS bridge
- GMP batch records
- Right-first-time
Patient Support+27% adherence
Patient support programme for a rare-disease pharma
HIPAA + GDPR-grade patient portal with adherence tracking and HCP messaging.
- Patient portal
- HIPAA + GDPR
- HCP messaging
Emerging Biopharma1 quarter to ready
End-to-end clinical platform for a Phase III biopharma
EDC, eCRF, ePRO, eConsent, and randomisation on one validated platform, with medical coding to WHODrug and MedDRA and an audit trail per subject, stood up in a single quarter for a Phase III programme.
- EDC + eConsent
- WHODrug / MedDRA coding
- Phase III ready
Platform expertise
Platforms we integrate against
Production integrations across every major pharma estate: clinical, regulatory, safety, and quality on one GxP-clean surface.
Connected. Unified. Audit-ready.
- Veeva Vault
- Medidata Rave
- Oracle Clinical / Argus
- IQVIA · ArisGlobal
21 CFR Part 11 baked in
Audit trails, e-signatures, and CSV evidence emit per release, every build is inspection-ready, not retrofitted.
SDTM and define.xml as code
Mappings live in the repo, gated in CI, regenerated on every CRF change, no late-stage scramble to lock before the CSR.
Validation pack ships with the build
IQ/OQ/PQ, traceability matrices, and risk assessments emit per release, QA reviews evidence that already exists.
Our engagement workflow
Seven stages from first call to ongoing support
Every engagement walks the same path, sized to your problem, but with the same verification gates baked in.
Phase 01Discovery
Two-week paid sprint. Architect-led. Output: regulator map, costed roadmap, signed scope.
Phase 02Planning
Pod composition, sequenced milestones, change-control governance, and risk register.
Phase 03Design
Reference architecture, threat model, design system, and acceptance criteria locked.
Phase 04Development
Weekly demos, trunk-based, CI/CD from day one. Code reviewed against spec at every gate.
Phase 05Testing
Unit, integration, e2e, security, performance, and accessibility, automated and gated.
Phase 06Deployment
Blue-green or canary, observability live before launch, rollback rehearsed.
Phase 07Support
Managed services or hypercare hand-off. Defined SLOs, named on-call, monthly reviews.
Success stories
Programmes we have shipped
9 weeks
Pharma
AI governance and model-risk framework for a pharma company
Stood up a board-ready AI governance and model-risk framework for a pharma company in 9 weeks, cleared at first internal audit.
GovernanceModel riskGxPEU AI Act
Country · CH
40%
Pharma
Legacy modernisation for a pharma manufacturer
Strangled a validated legacy system into microservices, cutting change lead time 40% for a pharma manufacturer.
JavaSpringKafkaOpenShiftOracle
Country · CH
8x
Pharma
GxP-compliant CI/CD for a pharma manufacturer
Delivered validated, GxP-compliant CI/CD, cutting release lead time 8x with full audit evidence.
GitLab CITerraformKubernetesAnsible
Country · CH
100%
Pharma
Data governance and catalogue for a pharma manufacturer
Catalogued and lineage-traced 100% of GxP-regulated data domains for a pharma manufacturer.
CollibradbtSnowflakeOpenLineage
Country · CH
12 weeks
Pharma
GxP and Annex 11 compliance for a pharma manufacturer
Reached validated Annex 11 compliance for a pharma manufacturer in 12 weeks.
GovernanceGAMP 5Annex 11Vanta
Country · CH
73%
Healthcare
Agentic procurement triage for an NHS trust
Routed and matched 73% of purchase requests end to end, escalating only genuine exceptions.
PythonLangGraphAzureSQL Server
Country · UK
54%
Telemedicine
Symptom-check and triage app for a telemedicine provider
Photo-and-symptom-first triage app cut consultation prep time 54% for a telemedicine provider.
React NativeTypeScriptAzure
Country · UK
900
Healthcare
Datacenter exit for an NHS hospital group
Migrated 900 clinical workloads off two datacentres to the cloud with zero downtime on patient-facing systems.
AzureTerraformAzure MigrateAnsible
Country · UK
99.98%
Telemedicine
24/7 SRE for a telemedicine platform
Ran a telemedicine platform to a 99.98% SLO with a follow-the-sun on-call.
KubernetesPrometheusPagerDutyTerraform
Country · UK
37%
Biotech
Managed FinOps for a biotech scale-up
Cut monthly cloud spend 37% for a genomics biotech without slowing a single pipeline.
AWSKubecostTerraformAWS Batch
Country · UK
38%
Healthcare
Claims and billing analytics for a hospital group
Unified claims and billing data, cutting rejected-claim rework 38% for a hospital group.
SnowflakedbtFHIRPower BI
Country · UK
24%
Telemedicine
Patient 360 for a telemedicine provider
Unified a fragmented patient view, lifting care-team efficiency 24% at a telemedicine provider.
SnowflakedbtPower BIFHIR
Country · UK
61
Healthcare
Penetration test for a hospital estate
Surfaced 61 exploitable paths across a hospital estate, prioritised by patient-safety impact.
ProwlerScoutSuiteCobalt StrikeNessus
Country · UK
first pass
Telemedicine
ISO 27001 and DTAC for a telemedicine platform
Achieved ISO 27001 and NHS DTAC assurance at first assessment for a telemedicine platform.
ISO 27001NHS DTACVantaGovernance
Country · UK
9
Biotech
Threat modelling a biotech lab-data platform
Identified nine design-level risks in a biotech's lab-data platform before build.
STRIDEAttack treesThreat modelling
Country · UK
Encryption verified
Healthcare
Penetration and data-protection testing for a credential vault
Penetration-tested the credential vault and its sync, verifying encryption and access controls end to end so stored secrets stayed protected.
Burp SuiteCryptographySASTDAST
Country · US
Audit-ready design
Healthcare
Health-data integrity and consent architecture advisory
Delivered an audit-ready blockchain architecture for tamper-evident patient records and consent, cleared against HIPAA and GDPR before build.
Solution architectureSecurity advisoryConsent / DIDCompliance
Country · SG
Who we are
About usBritonOne Technology is a full-cycle engineering company that builds and operates production software for regulated estates. Since 2017, we have shipped programmes that clear audit on the first pass across banking, insurance, wealth, healthcare, and biotech. Our teams pair deep domain knowledge with disciplined engineering, treating compliance, security, and resilience as first-class deliverables. From architecture through to live operations, we stay accountable for the systems we build, measuring success by uptime, audit outcomes, and defensible business results.
60+Senior engineers across UK and EU
Why choose us
Engineer experience, average9+ yrs
Specialist replacement window48h
Code and IP ownership, day one100%
Surprise invoicesZero
Why teams choose BritonOne Technology
Four reasons enterprise buyers come back
We don't compete on lowest day-rate. We compete on shipped outcomes inside environments that have to clear audit.
Senior-only delivery
Every engineer on every engagement is at least senior, typically eight to fifteen years deep in their craft. No bench rotations, no junior pyramid hidden behind a glossy proposal, no bait-and-switch after contract signature. The architect who scoped your engagement is the same person committing code by week three.
Audit-ready by default
FCA, PRA, EBA, BaFin, FINMA, HIPAA, SOC 2 Type II: every framework we work under is treated as a design constraint from day one, not a final-stage gate. Evidence trails, model-risk packs, change-control artefacts, and pen-test reports ship alongside the code, ready for second-line review without a remediation sprint.
Anti-drift delivery discipline
Small pods of three to seven engineers, each with a named delivery lead who owns scope, schedule, and outcomes from kickoff to hand-off, never a faceless team you have to chase for an answer. Weekly demos run against the signed scope, frequent verification gates catch regressions early, and quarterly outcome reviews measure real progress against the original business case rather than a moving target. Together those rituals catch scope drift before it has any chance to compound, so programmes that should take six months don't quietly stretch into eighteen, budgets stay anchored to what was agreed, and every milestone ships with a written, testable definition of done that both sides sign off before we move on.
Long-tail support beyond hand-off
We don't disappear the moment the engagement closes. Managed services, hypercare windows, named on-call rotations, or quarterly health checks: pick the depth that matches your operational risk profile. About seventy percent of clients return for a second programme, usually because the team that shipped the first one is still on the other end of the page.
Pharma client reviews
Words from the pharma teams we have shipped with.
Anonymous under MNDA. Each quote is from a senior pharma buyer who owned the engagement end to end.
First-Pass FDA Inspection
“First clinical platform of mine that cleared an FDA Part 11 inspection on the first attempt. The validation pack and audit trail were ready before the inspector walked in.”
VP Clinical OperationsTier-1 pharma, US
Pharma procurement questions
Things pharma buyers ask before signing the first SOW
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Before you sign
Direct answers to what procurement, security, and delivery leads weigh before signing: compliance, integration, and the accountability we put in writing.
Are you 21 CFR Part 11 and EU Annex 11 compliant?
Yes. We engineer to 21 CFR Part 11 and EU Annex 11 from day one, electronic signatures, audit trails, access controls, and computer system validation are first-class deliverables, not retrofitted before the inspection. We ship the IQ/OQ/PQ pack alongside each release and sit with your QA team through validation review.