5-Day Digital Trial Architecture Blueprint

Build a long-term architecture for your clinical data systems and operations – vendor- and country-agnostic.

Call to action

Ready for a digital trial architecture blueprint?
Book a short intro call or leave a message and we will confirm whether this is the right format for you.

Request4Proposal

Choose “Consultancy” and paste the product title into the text field.
Tell us what you need, what situation you’re in, and the timelines you’re working against.
The clearer your input, the sharper and faster we can prepare for your call — and move your project forward.

Book a Call (30 minutes)

What this service does

This is a strategy and design engagement for organisations that want a coherent, future-proof digital trial architecture.

We design how your:

TMF/ISF
eCRF/EDC, ePRO, eConsent
Data warehouses and analytics
Oversight and reporting tools

work together as one Clinical Data Systems (CDS) ecosystem, aligned with regulations and your business model.

Who it’s for

Growing or established sponsors with multiple studies
Companies considering platform consolidation or re-platforming
Organisations planning significant investment into digital clinical operations

What we do in 5 days

Day 1 – Strategy & constraints

Clarify business and clinical strategy (indications, geographies, outsourcing model)
Review current system landscape and contracts
Clarify regulatory and data residency constraints

Day 2 – CDS and process mapping

Map data flows from patient to analysis and submission
Identify duplicated steps, risks and single points of failure

Day 3 – Target architecture design

Design of target CDS architecture (systems, roles, interfaces)
Definition of core vs. optional components
Role of EasyClin (where applicable) within the landscape

Day 4 – Governance & validation

Outline of validation master plan (risk-based)
Vendor qualification approach and criteria
High-level change control and lifecycle management concept

Day 5 – Roadmap and business case

Prioritised rollout roadmap (18–36 months)
High-level budget estimate and resource implications
Executive summary (slides) for internal decision-making

Deliverables & Outcomes

You receive:

A 15–20 page blueprint document (PDF/Word)
An architecture diagram of your target CDS environment
A risk-based validation and vendor strategy outline
A phased implementation roadmap with budget ranges
An executive slide deck for your board or investors

You will be able to:

Make informed, long-term decisions about platforms and vendors
Explain your digital strategy clearly to auditors and investors
Plan budgets and timelines with much higher confidence
Reduce the risk of fragmented, non-compliant system growth