McKellar Institute
McKellar Institute
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Professional Certificate

AI in Clinical Research &
Trial Optimisation

Build AI capability for the way clinical trials are changing.

Explore how AI can support trial planning, feasibility, recruitment, operations, monitoring, data review and evidence generation — while maintaining the rigour, oversight and judgement clinical research demands.

Self-pacedOnlineCertification
Starting level
White Belt2–3 weeks— no AI experience required
Progression
yellow4–6 weeksgreen8–10 weeksblack10–12 weeks
Drop the certification visual here — e.g. trial operations dashboard or site map
Sample McKellar certificate
Professional Certificate awarded after every belt.
Verifiable. Shareable. Earned, not attended.
OverviewOutcomesBeltsFeesCredentialFAQStart White Belt

Built for clinical research. Enhanced by AI.

AI is already influencing how research teams review evidence, assess feasibility, identify trial risks, interrogate data and manage complex clinical-development workflows. But clinical research cannot operate on speed alone — evidence quality, traceability, patient safety and human oversight still matter. It is not simply about learning AI tools. It is about learning how to use AI within the standards of clinical research.

Plan

Use AI to support trial planning, feasibility and operational decision-making.

Optimise

Explore AI-supported recruitment, monitoring, risk and trial operations.

Evaluate

Judge AI outputs for reliability, bias and evidence quality.

Full progression outcomes

Build capability you can use in practice.

By completing the full progression — through to Black Belt — you'll develop the ability to:

Identify meaningful AI applications across the clinical-trial lifecycle
Use AI to support trial planning, feasibility and operational decision-making
Apply AI-assisted approaches to evidence review and protocol workflows
Evaluate AI-supported recruitment and site-selection approaches
Use AI to support monitoring, risk identification and quality oversight
Critically evaluate AI outputs for reliability, bias and evidence quality
Assess governance, privacy, transparency and human-oversight requirements
Progress towards evaluating and leading AI-enabled clinical-research initiatives
Your certification journey

One certification. Four levels of capability.

Start with the foundations and progress as far as your professional goals require.

White Belt · Foundation

Build the common foundation.

White Belt refreshes important concepts across the clinical-research lifecycle while introducing AI in the context of trial design, operations, evidence and oversight.

I understand.

Explain where AI can support the major stages of clinical research
Distinguish key AI approaches relevant to clinical-trial environments
Recognise current and emerging AI applications across trial planning, operations and data
Identify limitations associated with AI-generated clinical-research outputs
Understand fundamental issues around data quality, bias, privacy and human oversight
Recognise where AI should support — rather than replace — professional judgement
01Clinical research in an AI-enabled environment
02AI fundamentals for clinical research professionals
03AI across the trial lifecycle
04Evidence, reliability and validation
05Responsible AI in clinical research
06AI readiness
Knowledge Assessment

40 domain-specific multiple-choice questions covering AI terminology, clinical-research use cases, regulatory context, limitations and responsible use. Pass ≥75%, 14-day window, unlimited attempts within it.

Professional Reflection & Peer Exchange

A short professional reflection per module plus substantive responses to at least two peers. Mandatory, formative and ungraded.

At a glance
Level
Foundation
Study mode
100% online, self-paced
Learning time
8–15 hours
Typical completion
2–3 weeks
Assessment
Knowledge Assessment + Professional Reflection & Peer Exchange
Credential
McKellar White Belt Professional Certificate — Digital Credential
Ready when you are
Pay per belt, or save with a Pathway Plan.
Register NowView Fees & Plans

Your capability develops with every belt.

Understandwhite
Applyyellow
Integrategreen
Leadblack

Each belt builds on the capability developed at the level before it.

Real-world applications

Where could AI change the way you work?

The full range of applications below reflects capability developed across the complete progression to Black Belt.

Trial Feasibility

Interrogate evidence and operational information to support country, site and population feasibility.

Patient Recruitment

Support identification, segmentation and recruitment-planning workflows.

Protocol Development

Accelerate evidence interrogation and support more informed protocol planning.

Trial Operations

Reduce repetitive information handling and improve operational visibility.

Monitoring & Risk

Identify patterns and prioritise areas requiring professional review.

Clinical Data

Support structured review, anomaly identification and trial intelligence.

Evidence Synthesis

Accelerate literature discovery, screening and synthesis.

Documentation

Support drafting, extraction, summarisation and quality-review workflows.

Built for your profession

For professionals working where evidence becomes action.

Clinical Research AssociatesClinical Trial ManagersClinical Research CoordinatorsClinical Operations ProfessionalsClinical ScientistsClinical Data ProfessionalsMedical WritersQuality & GCP ProfessionalsInvestigators & ResearchersPharmaceutical & CRO Professionals
No programming knowledge required.
No data-science background required.
No previous AI experience required for White Belt.
Earn a verifiable credential

Demonstrate capability.
Don't just watch videos.

Each belt has scenario-based assessments that require you to apply your knowledge in realistic clinical-research contexts.

Applied activities and practical tasks
Scenario-based assessments
Professional-context evaluation
Progressive capability standards
McKellar White Belt Professional Certificate — AI in Clinical Research & Trial OptimisationMcKellar Yellow Belt Professional Certificate — AI in Clinical Research & Trial OptimisationMcKellar Green Belt Professional Certificate — AI in Clinical Research & Trial OptimisationMcKellar Black Belt Professional Certificate — AI in Clinical Research & Trial Optimisation
Certificate numberOnline verificationQR verificationDigital credentialShareable professional achievement
Assessment philosophy

Each belt answers a different question.

Assessment is applied and scenario-based — capability is demonstrated, not attended.

White Belt
Can you judge the fundamentals?
Knowledge + applied judgement
Yellow Belt
Can you apply AI to real problems?
Applied use + tool evaluation
Green Belt
Can you integrate and evaluate AI approaches?
Integration + capstone design
Black Belt
Can you lead and defend adoption decisions?
Implementation + professional defence

Overall indicative learning effort: approximately 120–165 hours across the full White-to-Black progression.

Choose how you progress

Start with White. Decide how far to go.

Each price is the fee for that single belt only — you pay per level, as you progress. All fees are in USD.

01
$399
White Belt
Foundation
02
$799
Yellow Belt
Practitioner
03
$1,399
Green Belt
Specialist
04
$2,299
Black Belt
Professional Leader

Pricing varies by country → View your fee

Not sure how far to go?

You don't need to decide today whether you'll complete all four belts.

New to AI in clinical research?White Belt
Building practitioner capability?White + Yellow
Want advanced capability?White → Green
Building toward leadership?Complete pathway

Regardless of how you pay, every learner begins at White and earns each belt sequentially.

What professionals say

Built for work beyond the classroom.

“The feasibility and monitoring examples mapped directly onto my day-to-day trial work. I started with White Belt and continued through Green.”

Sarah Mitchell
Clinical Research Associate · Australia
Green Belt

“It gave me the confidence to introduce AI-assisted evidence review in our CRO — responsibly and with proper oversight.”

Rajesh Menon
Clinical Operations Lead · India
Black Belt

“Practical, well structured and honest about the limitations of AI. The belt progression makes the capability real.”

Dr. Emma Larsen
Clinical Data Manager · Denmark
Yellow Belt

Illustrative testimonials — to be replaced with real learner feedback.

Want the details?

Take the certification guide with you.

Download the complete AI in Clinical Research & Trial Optimisation guide, including curriculum, learning outcomes, assessment, belt progression and fees.

Download Certification Guide (PDF)
Have a question? Let our team help.
Frequently asked questions

Certification-specific answers.

No. White Belt is designed to establish the AI foundation — no previous AI experience is required.

No. Every learner begins at White Belt, and each belt is a credentialed milestone in its own right.

Yes. McKellar offers both pay-as-you-go and multi-level Pathway Plans.

Yes. Each successfully completed belt earns its own McKellar Professional Certificate and verifiable credential.

No. The certification focuses on professional application rather than training you to become a programmer.

Yes. Progression remains sequential, so you can continue from the next belt when you are ready.

Assessment becomes progressively more applied — from foundational knowledge at White Belt to tool evaluation, workflow design, capstone work and professional defence at advanced levels.

Yes. It is relevant to professionals working across sponsors, CROs, research sites and other clinical-development environments.

Ready to begin?

Clinical trials are changing.
Build the capability to change with them.

Start with the foundations and progress from understanding AI to applying, integrating and ultimately leading its responsible use within clinical research.

Start White BeltDownload Certification Guide
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