Get a Ready-to-Use AI Governance Package

AI Governance Foundation Kit:
AI Policy Package

A complete, regulator aligned AI Policy Package including:
  • AI Policy
  • AI Inventory
  • AI Risk Register
  • AI System Impact Assessment (AIIA)
Built to support practical alignment with the EU AI Act, ISO 42001 principles, and GCP-relevant expectations for accountability, documentation, oversight, and risk-based control.
Do you recognize yourself?
AI tools are already being used throughout your organization (officially or inofficially).
Perhaps your teams are using ChatGPT, Microsoft Copilot, or other AI applications to support your clinical trials.

But questions keep coming up:
  • Which AI tools are employees using?
  • Who is responsible for oversight?
  • How should risks be assessed?
  • How should AI systems be documented?
  • What does the EU AI Act mean for our company?
  • What evidence would we show during an audit or inspection?


The reality is that many organizations know governance is required. They simply do not know where to start.
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Imagine instead...
Within the next few days, you could have:
  • A documented AI policy
  • A structured inventory of AI systems
  • A practical AI risk management process
  • A consistent AI impact assessment methodology
  • A framework you can customize to your organization


Instead of starting with a blank document and searching through hundreds of pages of regulations, you can begin with a proven structure that is already aligned with recognized AI governance principles.

The AI Governance Foundation Kit

The AI Policy Package provides the core documentation needed to define how AI may be selected, approved, used, monitored, and documented in a regulated clinical trial environment.
The package combines an AI Policy, AI Inventory, AI Risk Register, and AI System Impact Assessment (AIIA) so your organization can move from informal AI use to a documented governance baseline with defined responsibilities, risk controls, and traceable decisions.

What is included?

AI Policy

A ready-to-use policy that defines responsible AI use, accountability, permitted and prohibited use cases, human oversight, data privacy expectations, vendor-related AI use, risk management principles, training expectations, and organizational responsibilities.

AI Inventory

A central register for AI systems and AI-enabled tools, including purpose, intended use, owner, user group, data categories, supplier, AI Act classification, risk level, validation status, and approval status.




AI Risk Register

A structured register for identifying AI-related risks, evaluating impact and likelihood, documenting controls, assigning ownership, tracking residual risk, and maintaining governance evidence.

AI System Impact Assessment

A structured assessment template covering intended use, stakeholders, data governance, data privacy, patient safety, data reliability, human oversight, bias considerations, supplier dependency, and required controls.

Govern Artificial Intelligence Now!

Who is this AI Governance Foundation Kit for?

For companies that need practical AI governance documentation for responsible AI use in regulated clinical trial settings:
  • Biotechnology companies
  • Pharmaceutical companies
  • Sites
  • CROs
  • Central Laboratories and other Service Providers

Why is this AI Governance Foundation Kit different?

Many AI governance templates are written for general corporate environments.
Clinical research faces additional expectations around:
  •  Patient Safety
  •  Data Reliability
  •  Quality Systems
  •  Service Provider Oversight


This package was created specifically for organizations operating in the regulated clinical trial environment.
"We do not use AI tools."
That may be true today. But an AI policy is not only for companies that actively use AI tools.
It defines what is allowed, what is not allowed, who may approve future AI use, how external AI-enabled vendors are assessed, and how confidential, personal, clinical trial, or regulated data must be protected.
Even if you do not currently use AI internally, your organization may still be exposed through service providers, software features, customer requirements, AI-generated content, regulatory expectations, or employees experimenting with publicly available tools. A clear policy creates a controlled position before usage begins, rather than forcing the organization to reconstruct decisions later.

"We are only a small biotech company."

That is exactly why a structured starting point matters.

Smaller organizations typically have limited resources and cannot afford long governance projects and research for regulatory requirements. This package gives you a practical foundation that can be adapted as your company grows.


"We do not have an AI expert."
You do not need an in-house AI specialist to begin. The Policy Package provides structure, guidance, and a consistent approach so that quality, clinical operations, IT, or management teams can start building governance immediately. And if you are seeking external support, please feel free to get in touch. I am a certified AI Officer and can help you.
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Your Benefits at a Glance

  • Faster AI governance implementation
  • Consistent AI risk assessment across functions and projects
  • Clear responsibilities for approval, oversight, and documentation
  • Stronger audit and inspection readiness
  • Less dependence on ad hoc decisions and individual interpretation
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