AI Adoption Training
for Clinical Research
Compliance-ready training for every stakeholder in the clinical trial lifecycle — from sponsors to CROs — mapped to ICH E6(R3), FDA AI guidance, NIST, and the EU AI Act.
Training that never goes stale.
Aurelyn is built AI-native from the ground up — the curriculum is continuously updated as FDA, EMA, ICH, ISO, and global regulators evolve, with new courses added on a rolling basis. Subscribers always train on the latest regulatory intelligence, never an outdated snapshot.
Four frameworks converge in 2026.
Clinical AI used to be a quality concern. From 2026 onward it is a binding regulatory obligation across the EU, US, and ICH-aligned jurisdictions — training, validation, and audit-readiness are now in scope of formal inspection.
EU AI Act
Regulation 2024/1689
GPAI obligations enter force. Sponsors must demonstrate AI literacy (Art. 4) and risk-classify clinical decision support. Max penalty: €35M / ~$38M or 7% of global turnover.
ICH E6(R3)
Good Clinical Practice — revised
First GCP revision to explicitly address AI-assisted authoring, electronic-systems risk, and oversight of AI-derived outputs. Adopted by EMA, MHRA, Health Canada.
FDA AI Guidance
Docket FDA-2024-D-4689
Draft guidance on AI in drug-development decision-making. Sponsors must document AI model lifecycle, validation, and human oversight for AI feeding submissions.
NIST AI RMF 1.0
+ AI 600-1 GAI Profile
U.S. baseline for AI risk management. Adopted by FDA and NIH and increasingly written into sponsor contracts as a compliance prerequisite.
Every region. Every binding standard.
Courses cite specific clauses across every major regulatory jurisdiction worldwide — North America, Europe, Asia-Pacific, Latin America, the Middle East & Africa — plus the international ICH, ISO, and AI-governance frameworks. No "best-practices" filler.
🇺🇸 United States & Canada
- US Code of Federal Regulations — 21 CFR Parts 11, 50, 56, 312, 314, 320, 600, 812, 820
- FDA AI/ML Guidance · Docket FDA-2024-D-4689
- HHS / OHRP — 45 CFR 46 (Common Rule)
- Health Canada — Food & Drugs Act, Division 5
🇪🇺 European Union & UK
- EU AI Act — Regulation 2024/1689
- EU CTR 536/2014 · EMA Reflection Paper on AI
- EU GDPR 2016/679 · Annex 11 / EudraLex Vol. 4
- MHRA (UK) · Swissmedic (Switzerland)
🌏 Asia-Pacific
- PMDA (Japan) · NMPA (China)
- TGA (Australia) · CDSCO (India)
- MFDS (South Korea) · HSA (Singapore)
- Medsafe (New Zealand)
🌎 Latin America
- ANVISA (Brazil) · RDC 945/2024
- ANMAT (Argentina) · COFEPRIS (Mexico)
- INVIMA (Colombia) · ISP (Chile)
- PAHO / regional harmonisation
🌍 Middle East & Africa
- SFDA (Saudi Arabia) · SAHPRA (South Africa)
- DHA / MOHAP (UAE) · NPRA (Malaysia)
- NAFDAC (Nigeria) · EDA (Egypt)
- AUDA-NEPAD AMA harmonisation
🌐 International & Standards
- ICH E6(R3), E8(R1), E9(R1), E2A–E, E3, M4, M11
- WHO GCP · ISO 14155 · CDISC (CDASH/SDTM/ADaM/USDM)
- NIST AI RMF 1.0 + AI 600-1 · ISO/IEC 42001 · ISO 27001:2022
- ALCOA+ · GAMP 5 · Declaration of Helsinki
Seven progressive tracks. One clear pathway.
From AI fundamentals to advanced governance — a structured pathway for every role in clinical research, biotech, pharma, and CRO organisations.
AI Foundations for Life Sciences
Fundamentals, ML, generative AI, and global compliance.
AI for Clinical Research & Development
CRA workflows, monitoring, RBQM, project & data management.
AI for Regulatory & Medical Affairs
Medical writing, submissions, inspection readiness.
AI for Drug Development
Development strategy, RWE, decentralised trials.
AI Governance & Compliance
Risk, validation, policy, EU AI Act, inspection prep.
AI for Functional Teams
Role-specific PV, QA, data management, operations.
Advanced AI & Emerging Technologies
Validation in GxP, 21 CFR Part 11, emerging AI.
Stackable toward 5 certifications
ACACP™ · ACCAM™ · ACAGL™ · ACCAS™ · ACETMF™
40+ courses. Every role. Zero filler.
Every course maps to a curriculum track, taxonomy level, study lifecycle phase, and ICH / FDA / EU regulatory framework. Search and filter the live catalog below.
| Course | Track | Level | Frameworks |
|---|
Eight free courses. No credit card.
Professional-grade training at no cost — so individuals and teams can prove the value before they ever buy a seat.
Introduction to AI in Life Sciences
90–120 min · Beginner · 6 modules
AI for PowerPoint & Presentations
~2 hrs · Beginner
AI + Excel Mastery Guide
3–4 hrs · Beginner
Clinical AI Readiness Assessment
~2 hrs · Intermediate
Algorithmic Bias: Identification & Detection
~3 hrs · Intermediate
ICH/GCP Mastery for Modern Clinical Trials
~4 hrs · Intermediate
Dataset Bias & Integrity Audit
~2.5 hrs · Intermediate
From Compliance Chaos to Clinical Intelligence
~3 hrs · Advanced
Hands-on tools for the work you actually do.
Interactive AI training modules focused on AI adoption for repetitive and administrative clinical work — not abstract theory.
AI Prompting
Effective prompts for clinical workflows
Document Intelligence
AI-powered document analysis & review
Meeting Minutes
Automated meeting documentation
Status Reports
AI-generated project status reporting
eTMF Workflows
Streamlined Trial Master File management
Training by study lifecycle phase
Courses aligned to your current phaseThe eTMF Lab: a static reference, made immersive.
Transform the CDISC eTMF Reference Model into a dynamic, AI-powered learning experience — navigate zones, master filing, simulate inspections, and earn eTMF competency. Aligned with ICH E6(R3), FDA, EMA, and MHRA.
Interactive eTMF Explorer
Tree nav across all 10 zones, sections & artifacts
AI eTMF Tutor
Ask anything — grounded in ICH E6(R3)/FDA/EMA
Study Simulation
Build a virtual eTMF across 9 lifecycle stages
Filing Challenges
Gamified drag-and-drop drills, scored on accuracy
Inspection Readiness
Mock inspections with TMF risk scoring & findings
Role-Based Paths
Tailored journeys for 9 clinical-trial roles
All 250 artifacts across 11 zones & 44 sections — cross-referenced against 7 FDA-regulated sites (FDA 21 CFR 312 · ICH E6(R3) · EU CTR), filterable by owner, level & signature.
CDISC eTMF Reference Model — zone map
Mock TMF Inspection
Simulate a regulatory inspection of your Trial Master File. The system generates a realistic TMF seeded with common issues for you to identify and assess — then returns a completeness score, risk rating, and an actionable findings list.
TMF Review
Inspect all zones & artifacts
Risk Scoring
Completeness & risk metrics
Findings
Prioritised remediation list
Sneak peek — inside the eTMF Lab
Five stackable, verifiable credentials.
Each credential follows a curated course path culminating in a verifiable digital certificate — shareable to LinkedIn, with an 80% pass threshold that means something.
AI Clinical Professional
Clinical AI Manager
AI Governance Leader
Clinical AI Strategist
Certified eTMF Specialist
Learn alongside your peers.
The Aurelyn Community Forum
Connect with clinical research professionals, share insights, and discuss AI adoption in clinical trials — from prompt patterns and validation war-stories to inspection-readiness and governance. A moderated space built for sponsors, CROs, sites, and regulators navigating the same transition.
aurelynlifesciencesacademy.org/community-forum
Three tiers. Predictable USD economics.
Start free, scale to a full compliance curriculum, and license at volume for your organisation — all priced in US dollars.
- 8 free professional-grade courses
- Completion certificates
- Community discussion access
- SCORM progress tracking
- No credit card required
- Full 40+ course catalog path
- ICH E6(R3) · FDA · HIPAA · NIST · 21 CFR 11
- All 5 professional certifications
- SCORM 1.2 LMS tracking
- Dedicated account manager
- Everything in Professional
- Bulk seat licensing
- LMS integration (SCORM / xAPI)
- Custom curriculum & white-label
- Custom reporting & analytics
Founding Partner: 25% off first 24 months · Academic / non-profit pricing available · 14-day risk-free pilot · All figures in USD.
Why not the alternatives?
| Capability | Aurelyn Academy | Generic AI Training | DIY / Internal | Traditional Trainer |
|---|---|---|---|---|
| Clinical-specific scenarios | ✓ Real labs | ✗ None | △ Ad hoc | △ Limited |
| Regulatory citations | ✓ ICH/FDA/EU mapped | ✗ None | ✗ None | △ Outdated |
| Role-specific paths | ✓ 7 tracks | ✗ Generic | △ Variable | △ Discipline-based |
| Audit-ready certification | ✓ 5 creds + SCORM | ✗ Completion only | ✗ None | △ PDF only |
| eTMF mastery lab | ✓ 10-tool centre | ✗ None | ✗ None | ✗ None |
| EU AI Act + ICH E6(R3) | ✓ Built-in | ✗ None | △ As-of-date | △ 6–12mo lag |
| WCAG 2.1 AA accessibility | ✓ Verified | △ Vendor-dependent | ✗ Rare | △ Vendor-dependent |
| Time to deploy | ✓ < 14 days | ✓ Days | ✗ 6–18 months | △ 3–6 months |
Honest comparison — no straw men. Aurelyn is purpose-built for regulated clinical AI adoption, combining role-specific scenarios, binding regulatory citations, a dedicated eTMF lab, and audit-ready certification in one platform.
What does this actually return?
Illustrative Year-1 ROI · 300-FTE sponsor
Net benefit vs. blended Professional license
≈ 3.6× Year-1 ROI · < 4-month payback
Illustrative — internal modeling; customer-specific results will vary. Figures shown in USD.
Help build the future of AI-enabled clinical research.
Aurelyn AI Clinical Academy is one of the first AI-focused professional-development ecosystems dedicated exclusively to clinical research and life sciences. Founding sponsors are permanently recognised as the organisations that helped establish it — reaching 5,000+ professionals, 2,000+ learners, and a global audience across North America, Europe, Asia-Pacific, and Latin America.
Strategic partnerships also welcome — technology & AI vendors, CROs, professional associations, universities, and healthcare organisations — for co-developed content, webinar series, research initiatives, and workforce-development programs.
Become a Founding Partner or Sponsor
Tell us about your organisation and we'll send the full 2026–2027 prospectus and a tailored proposal. Inquiries route directly to the founder.
Join the Academy as a Founding Member.
Be among the first to shape the platform. Founding Member beta testers get early access to new courses and the eTMF Lab, a direct line to the founder, and Founding-rate pricing locked in.
Founding Member Beta Tester
Tell us a little about you and we'll send your beta invitation and onboarding details.
Founding Member benefits
- ✓ Early access to all new courses & the eTMF Lab
- ✓ Founding-rate pricing locked for 24 months
- ✓ Direct input into the curriculum roadmap
- ✓ Recognition on the Founding Members page
- ✓ A direct line to the founder during beta
"Be one of the first to define how clinical AI literacy is taught — and prove it."
Be one of the first to define how clinical AI literacy is taught.
Explore the live platform, start free, or talk to the founder about enterprise licensing and founding-partner terms.
Innovate. · Educate. · Elevate.