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3-Day Study Enablement Deep Dive

Design your operational model for upcoming trials – from feasibility to TMF/ISF and CDS integration.

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1 

What this service does

This package is for teams who have specific studies in the pipeline and need a coherent, inspection-proof operating model – not just isolated tools.

Over three days, we translate your study pipeline into a practical setup covering:

  • Feasibility and site engagement

  • TMF/ISF architecture and responsibilities

  • Integration with your Clinical Data Systems (CDS)

2

Who it’s for

  • Biotech/Medtech/Diagnostics with defined study plans (or running early trials)

  • Sponsors working with CROs and multiple sites

  • Organisations preparing for first multi-country or pivotal trials

3

What we do in 3 days

Day 1 – Pipeline & process mapping

  • Review of your upcoming or ongoing studies

  • Mapping of sponsor–CRO–site responsibilities

  • Identification of pain points around setup, feasibility, TMF/ISF and data flow
     

Day 2 – Operational design

  • Design of feasibility and site-engagement workflow

  • Proposed TMF/ISF folder structure and roles (e.g. based on DIA/EMA)

  • Definition of how CDS components (eCRF, ePRO, labs, imaging etc.) tie into operations
     

Day 3 – Implementation concept

  • Definition of roles, responsibilities and minimal SOP framework

  • Draft implementation roadmap (6–18 months)

  • One tailored SOP outline (e.g. “TMF/ISF Management” or “Feasibility Workflow”)

4

Deliverables & Outcomes

You receive:

  • A visual process map for study setup and execution

  • A TMF/ISF concept (structure, responsibilities, oversight)

  • A description of CDS integration points

  • An implementation roadmap with milestones

  • One SOP outline you can expand internally

 

You walk away with:

  • A concrete model for running your next studies

  • Less ambiguity between sponsor, CRO and sites

  • Clear expectations for vendors and internal teams

  • A foundation for validation, audits and inspections

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