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5-Day Digital Trial Architecture Blueprint

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

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Tell us what you need, what situation you’re in, and the timelines you’re working against.
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1 

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.

2

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

3

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

4

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

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