AI Operating System for Clinical Trials

Where AI Meets Clinical Integrity

Aurelyn AI
Clinical Academy
& Life Science Solutions

The AI Operating System for compliant, quality, and patient-first clinical trials — engineered to accelerate the delivery of medicines to patients through intelligent, auditable, and role-aligned clinical research infrastructure.

Explore the AI Engines Learn by Your Role
563+
Trial Activities Mapped
8+
Regulatory Frameworks
AI‑OS
Not a Platform
Aurelyn AI Clinical Engines™ — AI Operating System

Not a Platform. An AI Operating System
for Clinical Trials

Aurelyn AI Clinical Engines™ is the operating layer that runs beneath every compliant, quality, and patient-first clinical trial — automating intelligence, ensuring consistency, and keeping human judgment at the center of every decision.

Engine 01 / 02

Aurelyn AI eTMF
Intelligence Engine™

Document Intelligence & Inspection Readiness

Transforms the electronic Trial Master File from a compliance obligation into a living intelligence asset. AI-powered classification, automated completeness scoring, and real-time inspection readiness dashboards ensure your eTMF is always audit-ready — without manual effort.

  • AI document classification & metadata extraction
  • Real-time completeness & quality scoring
  • CDISC Reference Model aligned structure
  • 21 CFR Part 11 audit trail & e-signatures
  • Inspection readiness dashboard & gap analysis
  • Cross-study deviations & risk flagging
Engine 02 / 02

Clinical Evidence &
Consistency Engine™

Data Integrity & Protocol Alignment

Ensures every data point, protocol deviation, and clinical narrative is consistent, traceable, and submission-ready. The engine applies AI to detect inconsistencies across sites, monitors, and datasets — protecting patient safety and data integrity across the full trial lifecycle.

  • Cross-site data consistency monitoring
  • Protocol deviation detection & classification
  • AI narrative consistency review
  • Patient safety signal correlation
  • Submission-ready clinical evidence packaging
  • ICH E6(R2) risk-based monitoring alignment
Role-Based Learning Paths

Training Built for Your Role
in Clinical Research

Every professional on a clinical trial thinks differently. Our curriculum is organized by role so learning is immediately relevant and regulatory-aligned — each course grounded in ICH-GCP, global policy, and the specific frameworks that govern your daily work.

Clinical Research Associate / Monitor

Monitor Sites with AI-Augmented Precision

CRAs are the eyes and ears of a clinical trial. This learning path equips you to leverage AI for more effective monitoring visits, smarter deviation detection, and eTMF completeness tracking — so you spend less time on paperwork and more time protecting patient safety.

  • Apply AI tools to risk-based monitoring workflows
  • Use eTMF Intelligence Engine for completeness checks
  • Document deviations in compliance with ICH E6(R2)
  • Navigate 21 CFR Part 11 electronic records requirements
Start This Path
01
Foundational

AI in Clinical Operations: Foundations & Regulatory Landscape

4.5 hrs8 modulesSCORM 1.2Bloom's: Remember → Understand
ICH E6(R2)21 CFR Part 11EMA GCPHIPAAEU AI Act
02
Intermediate

eTMF Management & AI-Powered Document Intelligence

3 hrs6 modulesSCORM 1.2Bloom's: Apply → Analyze
ICH E6(R2) §8CDISC TMF Reference21 CFR Part 11EMA CTRGAMP 5
03
Intermediate

Risk-Based Monitoring & Source Data Verification with AI

2.5 hrs5 modulesSCORM 1.2Bloom's: Apply → Evaluate
ICH E6(R2) §5.18FDA RBM GuidanceEMA RBM ReflectionMHRA
Clinical Trial Manager

Orchestrate Trials at Scale with AI Oversight

CTMs oversee the full operational picture. This path builds your capability to use AI-driven dashboards, consistency engines, and risk-based strategies to keep multi-site, multi-country trials on time, on budget, and on-protocol.

  • Design AI-augmented risk management frameworks
  • Use Clinical Evidence Engine for cross-site consistency
  • Build AI-powered trial timelines & milestone tracking
  • Lead sponsor/CRO communications with AI-generated insights
Start This Path
01
Intermediate

AI-Powered Clinical Trial Design & Protocol Optimization

4 hrs8 modulesSCORM 1.2Bloom's: Analyze → Evaluate
ICH E8(R1)ICH E9(R1)ICH E17FDA Adaptive DesignsEMA Protocol Design
02
Intermediate

Risk-Based Monitoring with AI: ICH E6(R2) Applied

3 hrs6 modulesSCORM 1.2Bloom's: Apply → Evaluate
ICH E6(R2) §5FDA RBM GuidanceEMA RBM ReflectionTransCelerate RBM
03
Advanced

Clinical Evidence & Consistency Engine: Manager Certification

3.5 hrs7 modulesSCORM 1.2Bloom's: Evaluate → Create
ICH E6(R2)ICH E2A–E2F SafetyCDISC CDASH21 CFR Part 312
Regulatory Affairs Professional

Navigate the Global AI Regulatory Landscape

Regulatory professionals must now understand both the traditional frameworks and the emerging AI governance layer. This path covers EU AI Act, FDA guidance on AI/ML, 21 CFR Part 11, and how AI outputs become defensible submission evidence.

  • Interpret EU AI Act obligations for high-risk clinical AI
  • Apply FDA AI/ML guidance to IND/NDA submissions
  • Evaluate AI system validation under GAMP 5
  • Build regulatory-defensible AI documentation packages
Start This Path
01
Intermediate

21 CFR Parts 11, 50, 56 & Data Integrity in the AI Era

2.5 hrs5 modulesSCORM 1.2Bloom's: Understand → Apply
21 CFR Part 1121 CFR Part 5021 CFR Part 56FDA eSignatureALCOA+
02
Advanced

EU AI Act & Global AI Governance for Life Sciences

3.5 hrs7 modulesSCORM 1.2Bloom's: Analyze → Evaluate
EU AI Act 2024EMA AI GuidanceFDA AI/ML Action PlanWHO AI EthicsGDPR Art. 22
03
Advanced

GAMP 5 & Computerized System Validation for AI Tools

3 hrs6 modulesSCORM 1.2Bloom's: Apply → Create
GAMP 5 2nd Ed.21 CFR Part 11EMA Annex 11PIC/S GMPICH Q10
Data Management & Quality Assurance

Ensure AI-Era Data Integrity & Quality Standards

Data managers and QA professionals are the gatekeepers of trial integrity. This path covers AI-driven data validation, CDISC alignment, GCP audit principles, and how to evaluate AI system outputs against regulatory quality standards.

  • Apply ALCOA+ principles to AI-generated data
  • Conduct GCP-compliant audits of AI clinical systems
  • Validate AI outputs for CDISC submission readiness
  • Build data quality frameworks for AI-augmented trials
Start This Path
01
Foundational

AI in Clinical Operations: Foundations & Regulatory Landscape

4.5 hrs8 modulesSCORM 1.2Bloom's: Remember → Understand
ICH E6(R2)21 CFR Part 11ALCOA+EMA GCP
02
Intermediate

21 CFR Part 11, ALCOA+ & Data Integrity for AI-Generated Records

2.5 hrs5 modulesSCORM 1.2Bloom's: Apply → Analyze
21 CFR Part 11ALCOA+CDISC CDASHCDISC SDTMICH E6(R2) §5
03
Advanced

AI Quality Systems, CDISC Alignment & Audit Readiness

3 hrs6 modulesSCORM 1.2Bloom's: Evaluate → Create
ICH Q10CDISC SDTM/ADaMGAMP 5FDA Data StandardsEMA Annex 11
CRO & Sponsor Leadership

Lead AI Transformation Across Your Organization

C-suite and VP-level leaders need strategic AI literacy and regulatory awareness. This path equips you to evaluate AI investments, govern AI deployments under ICH and global policy, and position your organization competitively in an AI-first clinical landscape.

  • Build an AI adoption roadmap aligned to ICH-GCP and regulatory strategy
  • Evaluate AI vendor claims against FDA, EMA, and EU AI Act requirements
  • Govern AI risk in patient-facing research contexts globally
  • Drive competitive differentiation through an AI Operating System strategy
Start This Path
01
Strategic

AI Adoption Playbook for Clinical Research Leaders

2.5 hrs5 modulesSCORM 1.2Bloom's: Evaluate → Create
ICH E6(R2)FDA Strategic PlanEU AI ActWHO AI Policy
02
Advanced

EU AI Act & Global AI Governance for Life Sciences Leaders

3.5 hrs7 modulesSCORM 1.2Bloom's: Analyze → Evaluate
EU AI Act 2024FDA AI/ML Action PlanEMA AI GuidanceICH E6(R2)GDPR
03
Advanced

AI-Powered Clinical Trial Design & Global Regulatory Strategy

4 hrs8 modulesSCORM 1.2Bloom's: Analyze → Create
ICH E8(R1)ICH E17FDA Adaptive DesignsEMA InnovationPMDA
Site Staff & Principal Investigators

Protect Patients & Uphold GCP at the Point of Care

Site coordinators and PIs bear the frontline responsibility for patient safety and data integrity under ICH-GCP. This path delivers practical GCP compliance, AI-assisted adverse event reporting, eConsent, and ICF documentation — built for the realities of a busy clinical site.

  • Apply ICH E6(R2) GCP principles in AI-assisted site workflows
  • Document adverse events and SAEs per ICH E2A and FDA requirements
  • Manage eConsent and patient data under HIPAA, GDPR, and 21 CFR Part 50
  • Prepare for sponsor monitoring visits with AI-powered readiness tools
Start This Path
01
Foundational

AI in Clinical Operations: Foundations & Regulatory Landscape

4.5 hrs8 modulesSCORM 1.2Bloom's: Remember → Understand
ICH E6(R2)21 CFR Part 11EMA GCPHIPAA
02
Foundational

Patient Safety, GCP & AI-Assisted Adverse Event Reporting

2 hrs4 modulesSCORM 1.2Bloom's: Understand → Apply
ICH E2AICH E6(R2) §421 CFR Part 312EMA Safety ReportingMedDRA
03
Intermediate

eConsent, Informed Consent & Data Privacy: HIPAA, GDPR & 21 CFR Part 50

2.5 hrs5 modulesSCORM 1.2Bloom's: Apply → Evaluate
21 CFR Part 50ICH E6(R2) §4.8HIPAAGDPR Art. 945 CFR Part 46
Global Regulatory Coverage

Every Course & Engine Built on
the Frameworks That Govern Clinical Research

Aurelyn AI Clinical Engines and all Academy courses are designed from the ground up around the complete global regulatory stack — from ICH-GCP guidelines to FDA, EMA, and emerging AI governance policy. Compliance is an output, not an afterthought.

ICH E6(R2) / E6(R3) GCP

The global gold standard for Good Clinical Practice. Every course aligns to ICH-GCP principles covering trial conduct, data integrity, informed consent, and investigator responsibilities — applicable across FDA, EMA, PMDA, and Health Canada jurisdictions.

ICH E8 / E9 / E17

General Considerations for Clinical Studies (E8 R1), Statistical Principles (E9 R1 — estimands), and Multi-Regional Clinical Trials (E17) — essential frameworks for protocol design, statistical analysis, and global submission strategy.

21 CFR Parts 11, 50, 56, 312

FDA regulations covering electronic records & signatures (Part 11), informed consent (Part 50), IRB requirements (Part 56), and IND applications (Part 312) — the complete US regulatory framework for clinical research operations.

EMA GCP & EudraLex Vol. 10

European Medicines Agency GCP guidelines, EU Clinical Trials Regulation (EU CTR 536/2014), and EudraLex Volume 10 — governing all clinical trials conducted in the European Economic Area and informing global submission strategy.

EU AI Act & GAMP 5

EU AI Act obligations for high-risk clinical AI systems, and GAMP 5 (2nd Edition) for computerized system validation — ensuring every AI tool deployed in a regulated clinical environment meets global validation and governance requirements.

HIPAA · GDPR · CDISC · WCAG AA

US & EU health data privacy (HIPAA/GDPR), CDISC CDASH/SDTM data standards for regulatory submission, and WCAG 2.1 AA accessibility — ensuring every output is privacy-safe, submission-ready, and universally accessible.

Live Webinar — May 21, 2026

AI-Powered Clinical Research:
From Compliance to
Competitive Edge

Expert panel deep-dive: how Aurelyn AI Clinical Engines are redefining compliant, quality, and patient-first trial operations. Interactive Q&A. Free to attend.

Date: Wednesday, May 21, 2026
Time: 2:00 PM – 3:30 PM EDT
Audience: CRAs, CTMs, Regulatory Affairs, CRO & Sponsor Leadership
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