Transformation that survives the inspection, not just the business case.
Clinical operations digitalisation under GxP and device rules — every system, device, integration and algorithm you introduce assessed inside one reproducible regulatory framework, in five gated phases you fund one at a time.
Most transformation programmes fail the inspection, not the business case
Clinical operations transformation is usually sold as an efficiency exercise: consolidate the
systems, automate the manual work, move delivery somewhere cheaper, watch cost per trial fall. The
business case is rarely wrong. What goes wrong is everything the business case did not model — that
each new system, device, integration and algorithm you introduce carries regulatory obligations, and
that those obligations stack.
A programme that automates TMF completeness checks has introduced a GxP-impacting system. One that
moves delivery to a new country has moved personal data across a border. One that adds an enrolment forecasting model needs an EU AI Act classification check — few such tools will be high-risk, but the answer has to be on record. Each is defensible. None is defensible afterwards, in front of an
inspector, if nobody wrote down why at the time.
We run transformation as a controlled loop rather than a project plan. Same seven perimeters, same
register, same evidence — applied to the whole estate instead of one device.
Who this programme is for
This is for organisations running multiple trials, multiple vendors and multiple systems —
where DHT governance cannot stay in a project folder because the portfolio shares devices,
platforms and data flows. Typical sponsors arrive when:
A transformation board has approved budget but not regulatory ownership.
eClinical consolidation is underway and nobody has mapped validation scope across vendors.
Inspection findings cited change control or data integrity across systems, not one application.
AI and automation initiatives need a recorded AI Act classification, not a policy deck.
The transformation, expressed as the method
Five things have to be true at the end. They map exactly onto the perimeter model, because they are the same work at a different scale.
A complete inventory
Every system, device, sensor, integration and algorithm that touches the trial — eClinical platforms, eCOA, wearables, point-of-care devices, participant-owned phones, lab and manufacturing-adjacent systems. You cannot govern what nobody has listed, and in most organisations no such list exists.
A Regulatory Impact Assessment across the stacked perimeters
Each item assessed against all seven perimeters at once — medical device, GxP and CSV, data protection, human factors, configuration and change, economic-operator role, endpoint and protocol — because the risk lives in the combination, not in any single one.
Controlled change management for apps, firmware, OS and algorithms
A transformation is a continuous stream of change. Each release, OS update, model retrain or vendor swap is classified — documentation only, bridging evidence, or full revalidation — against a rule written before anyone was under deadline pressure.
ALCOA+, 21 CFR Part 11, EU GMP Annex 11 and the EMA guideline on computerised systems and electronic data in clinical trials applied where the data is actually created — on the handset, the sensor, the analyser — not only in the validated database it eventually reaches. This is the gap most CSV programmes leave open.
The register, classification rationale, validation evidence, training records and change history assembled as they are produced — so an inspection is a retrieval exercise rather than a three-week fire drill.
Five phases, five gates, one phase funded at a time
Transformation programmes go wrong financially when a sponsor commits to eighteen months of work
on the strength of a slide. We run five sequenced phases over roughly 18–24 months. Each is a
self-contained, fixed-fee commitment ending in a decision gate, and each has to earn the right to the
next. If Discovery does not produce a case you believe, the programme stops there and you have paid
for one phase and gained a baselined picture of your own operation.
What changes after each gate
Each phase ends with evidence, not optimism:
Discovery & Diagnose — baselined metrics, inventory of systems and devices, and a
case for whether the programme should continue.
Design & Business Case — target architecture with regulatory controls named per system and
perimeter, not a future-state diagram.
Build & Pilot — validated increments with change records that link to the trigger
register.
Scale & Transition — cutover evidence, training completion by role and version, and
updated inspection indexes.
Stabilise & Handover — an operating rhythm for monitoring, re-assessment and portfolio governance, run in your QMS today and in Device360 as the platform comes online.
You fund the next phase only when the gate passes — which is how transformation survives
both the CFO and the inspector.
Seven workstreams, running across every phase
Regulatory and quality is a workstream, not a review at the end. That is the structural difference.
Operating model
Roles, processes and sourcing — who does what, where, and how the next trial costs less than the last.
Delivery capability
Standing up scalable delivery and shifting work into it without losing control or institutional knowledge.
AI transformation
Validated, GCP-compliant automation — TMF checks, feasibility, enrolment forecasting, risk-based monitoring, coding, drafting — with model risk, drift and change control handled from the start.
Platform deployment
The connected stack on your existing foundation, configured so the trial is inspection-ready by default rather than by remediation.
Change management
Communications, training and adoption — and protecting morale through a transition that people correctly read as a threat until it is explained.
Governance
Steering, decision gates, RAID and the controls that keep the programme on time, on budget and on benefit.
Regulatory & quality
GCP, CSV/CSA, data integrity and data residency held intact end to end. Inspection-readiness by design, assessed continuously rather than audited at the end.
How the value is proved, not asserted
Six metrics are baselined in Discovery and movement is demonstrated at every later gate. They are
what convert a transformation from a promise into evidence — and they are agreed before any money is
committed to build.
Cost per trial — whether cost is genuinely decoupling from pipeline growth.
Cycle time — whether trials move faster through start-up, conduct and close-out.
Enrolment speed — whether patients are recruited sooner and critical-path risk falls.
Audit findings — whether inspection-readiness is real. This is the one most
programmes decline to measure.
Automation rate — whether manual effort is being removed under control.
FTE per trial — whether capacity is decoupling from headcount.
If the numbers do not move, the gate does not open. That is the point of gates.
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