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2-Day Strategy Sprint: Clinical Digital Readiness

A focused health check of your clinical digital setup – with a clear roadmap instead of a 60-page report.

Call to action

Ready for a clinical digital reality check?
Book a short intro call or leave a message and we will confirm whether the 2-Day Strategy Sprint is the right format for you.

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.

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What this service does

Many biotech, medtech and diagnostic companies grow faster than their processes. Systems are added “on the fly”, documentation is scattered, and nobody has a complete overview.

In two days, we assess your current setup and define a pragmatic, risk-based roadmap across TMF/ISF, eCRF/EDC and your overall Clinical Data Systems (CDS) – all digital components involved in capturing, managing and using clinical trial data.

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Who it’s for

  • Early- to mid-stage (pre-clinical to Phase II/III)

  • Biotech, medtech, diagnostics and digital health

  • Teams planning new trials, scaling into multiple countries, or preparing for first sponsor/CRO audits

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What we do in 2 days

Day 1 – Discovery & gap analysis

  • Short, structured interviews with key stakeholders (clinical operations, QA, IT)

  • Review of current TMF/ISF approach, eCRF/EDC, feasibility and vendor landscape

  • Identification of main compliance and efficiency risks (GCP, Annex 11, 21 CFR Part 11, data privacy)

 

Day 2 – Prioritisation & roadmap

    • Mapping of quick wins vs. structural changes

    • High-level CDS architecture aligned with your business strategy

    • Joint working session to agree priorities and timelines

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Deliverables & Outcomes

You receive:

  • A one-page heatmap of your current digital maturity

  • A clear list of risks and opportunities, with priorities

  • A 6–12 month roadmap for clinical digital improvements

  • A short executive slide deck for internal stakeholders and investors

 

After the sprint you:

  • Know where the real risks and bottlenecks are

  • Can argue investment needs with clear, quantified rationale

  • Have a realistic plan to align processes, systems and vendors

  • Avoid trial delays caused by fragmented digital infrastructure

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