No posts published in this language yet
Once posts are published, you’ll see them here.
top of page
3-Day Study Enablement Deep Dive
Design your operational model for upcoming trials – from feasibility to TMF/ISF and CDS integration.
Call to action
Ready for a study enablement deep dive?
Book a short intro call or leave a message and we will confirm whether this 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.
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
bottom of page