Expertise
The EU AI Act Readiness Playbook
Operationalizing “Invisible AI” Defense & Digital Omnibus Readiness for US Biotech
- Stop “Silent Updates” from corrupting your trial data.
- Align FDA “Context of Use” with EU traceability rules.
- NEW: Future-proof your data for the EU Digital Omnibus Regulation (2026).
- Includes: The 30/60/90 Day Readiness Roadmap.
The problem
You didn’t buy “AI.” But your vendors did.
In 2026, the biggest risk to your EU trial isn’t the software you build—it’s the “Invisible AI” embedded in the platforms you already use.
From recruitment matching algorithms to imaging segmentation, AI is now part of the standard trial stack. But under the new EU AI Act, if you cannot reconstruct how an algorithm made a decision, your data integrity is at risk.
The New “Digital Omnibus” Threat
It is tempting to solve this by filing static PDF memos. But the newly proposed Digital Omnibus Regulation signals a shift toward automated, “Once-Only” reporting.
If your oversight evidence is trapped in unstructured documents today, you are building a massive migration headache for tomorrow. You need evidence that is not just legally defensible, but digitally structured.
Download the Playbook
The solution
Not a White Paper. An Execution Guide.
We created this Playbook to move beyond legal theory. It provides the specific operational tools US sponsors need to de-risk EU trials immediately.
What You Will Get:
✅ The 30/60/90 Day Roadmap
A prioritized timeline to identify and govern AI exposure without stalling study start-up.
✅ The Vendor Risk Tiering Model
A practical framework to classify vendors as Tier A (Trial Critical) or Tier B (Operational)—so you stop auditing everything.
✅ The “No Silent Changes” Contract Clause
Copy-paste language to prevent vendors from pushing algorithmic updates that alter your data comparability mid-study.
✅ NEW: Digital Omnibus Preparation
How to structure your “Evidence Pack” (logs and registers) to meet the coming automated reporting standards.
Your Compliance Shield in Europe
Regulators don’t inspect intentions; they inspect records.
Accelsiors acts as your compliance shield, ensuring your global study meets FDA credibility standards, EU traceability rules, and the new Digital Omnibus automation requirements. We ensure your records exist—and are structured correctly—before the inspection happens.
Includes PDF Playbook
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