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One-Week FastTrack for US & GCC Market Readiness

Prepare your clinical digital operations for US and GCC requirements – fast, concrete and investor-ready.

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Ready to extend your business or need support from our partners from North America?

Get in touch to see if the FastTrack is the right entry point for your expansion.

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

Expanding into the US or GCC requires more than translating protocols. Your systems, data flows and contracts must stand up to:

  • HIPAA and BAAs (US)

  • 21 CFR Part 11

  • Local data residency and transfer rules in GCC countries

  • Expectations of partners, hospitals and regulators

In one week, we perform a focused compliance and readiness assessment of your clinical operations and Clinical Data Systems (CDS) and turn it into a clear action plan and narrative.

2

Who it’s for

  • Companies planning US or GCC clinical activity in the next 6–24 months

  • Organisations negotiating with US/GCC partners or investors

  • Teams using or planning cloud-based TMF/ISF and CDS for cross-border work

3

What we do in one week

  • Review of your current TMF/ISF, eCRF/EDC and hosting setup

  • Gap analysis vs. HIPAA, 21 CFR Part 11 and local data laws (high level)

  • Identification of critical contract changes (DPAs, BAAs, SLAs)

  • Recommendations on hosting models and data residency

  • Development of a short, investor-ready compliance story

 

Where applicable, we include options for US-based support and implementation via partners (e.g. CyberActa, GLSA, MRMC).

4

Deliverables & Outcomes

You receive:

  • A US/GCC readiness checklist with clear “pass/fail” items

  • A prioritised CAPA-style action list

  • Recommended hosting and data transfer model

  • A short slide deck you can use with partners and investors

 

After this FastTrack, you:

  • Understand where you stand regarding US/GCC expectations

  • Have a concrete list of must-do changes (and what can wait)

  • Can speak confidently about your compliance position in discussions

  • Reduce the risk of late-stage surprises in deals or inspections

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