Doctor.One — Care beyond visits

Five stages

Implementation Readiness Plan

Annex 11 and Part 11 are not certificates you hold. Compliance is shown through validation records, sponsor audits and regulator inspections.

AStage 1/5

Doctor.One today

Now · no GCP validation

  • GDPR-compliant processing of health data
  • ISO 27001 certified
  • Own clinic: a healthcare provider in its own right
  • Four years handling medical data

Time

Now

Unlocks

Support around a trial with the hospital record as source; real-world and observational studies with Doctor.One as the data source.

B1Stage 2/5

First qualified module set

Fastest step · the first milestone of B2's programme

  • Narrow scope: eDiary, symptom ePRO, adverse-event reports, messaging
  • A named sponsor and study, ideally an academic trial
  • Interim Head of Quality from month 1; validation consultancy from the start
  • Trial-specific GDPR agreements and consent; 25-year archive (EU CTR Art. 58)
  • Validation under the EMA 2023 guideline for this scope

Time

About 9 months to audit-ready for this scope, if every condition holds. The sponsor's own audit follows.

Unlocks

Doctor.One as source for what participants report from home.

B2Stage 3/5

Full EU GCP qualification

Same programme, continued

  • Remaining modules: intake, eCOA endpoints, remote monitoring, eCRF transfer, risk views
  • Permanent Head of Quality and a QA specialist
  • Sponsor qualification audits passed (there is no EU certificate)
  • Instrument licences; ICH E6(R3) incl. Annex 2

Time

15–24 months from start to audit-ready for the full scope

Unlocks

Endpoint data, a validated link to the eCRF, reuse across sponsors.

CStage 4/5

FDA add-on

Only for US sites or FDA submissions

  • 21 CFR Part 11 controls: audit trail, electronic signatures, validation
  • SOC 2 Type II, which US sponsors expect
  • There is no FDA certificate

Time

Inside B's timeline if designed in from day one; SOC 2 needs a 6–12 month observation window

Unlocks

FDA-regulated trials and US sites. Not needed for EU-only trials.

DStage 5/5

Medical device

Only if the regulatory assessment says so

  • CE mark via a notified body
  • ISO 13485, built on B's quality system
  • IEC 62304, ISO 14971, clinical evaluation, post-market surveillance
  • EU only: US use needs separate FDA device clearance

Time

Parallel track from month 2; notified-body queue 9–24 months

Unlocks

Software that interprets data to support clinical decisions.

Capability by stage

Doctor.One elements, stage by stage

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Tap any tag to read what it means at that stage.

ADoctor.One today
B1First qualified module set
B2Full EU GCP qualification
CFDA add-on
DMedical device

Messaging & care-team routing

Asynchronous participant ↔ site channel

Reminders & scheduling

Dosing, diaries, visit windows

Medication intake monitoring

Ongoing adherence to study and other drugs

Recruitment & feasibility

Before anyone is a participant

Real-world & observational studies

Non-interventional, outside ICH E6

Routine-care records as source

Doctor.One's own clinic records

Screening intake

Medical history and current medicines, once

eDiary

Participant diary for events and protocol entries

ePRO — safety symptoms

Symptom tracking between visits

Adverse event capture

Participant-reported events

Visit preparation

Pre-visit brief for investigator and coordinator

eCOA — protocol instruments

Validated questionnaires named as endpoints

Remote patient monitoring

Connected home devices

Risk assessments based on data

Operational and patient-level risk

Connection to eCRF

The sponsor's EDC

What applies in a given trial depends on its protocol and the sponsor's choices.

The technology stack

CT system map

The sponsor (or its CRO) chooses and pays for almost every system. The site works inside all of them, plus its own hospital records. The participant sees at most one or two. Vendor names are common examples, not a market map.

Doctor.One productBiorce domainDoctor.One integration: automatic data feed into the sponsor's system
2Doctor.One runs it0Automatic data feed5Supports the site manually3Biorce domain