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Aurelyn AI Clinical
AURELYN AI CLINICAL AI-Powered Clinical Research Intelligence
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🎙️ LIVE WEBINAR  |  MAY 21, 2026
From Compliance Chaos
to Clinical Intelligence

How Artificial Intelligence Is Transforming Clinical Research Operations in 2026 — and How You Can Lead That Change

👩‍🔬 Sheilah Johnson-Rocha, MSc.
⏱️ 45–60 Minutes
🏛️ Aurelyn AI Clinical Academy
What You'll Walk Away With

By The End of This Session…

🧠 UNDERSTAND
Exactly why clinical trials are failing — and why the old way of working no longer holds up in a data-driven world.
🛡️ KNOW
How AI can slash audit risk, end document chaos, and bring consistency to your clinical operations — without replacing your team.
🗺️ HAVE
A clear, 90-day roadmap you can actually start on Monday — whether you're a CRA, a manager, or a C-suite leader.
⚡ DISCOVER
The Aurelyn AI Clinical Trial OS™ — a first-of-its-kind operating system purpose-built for intelligent clinical research.

No technical background required. If you work in clinical research, this session is for you.

Your Guide Today

Meet Your Host

SJ
Sheilah Johnson-Rocha, MSc.
Founder & Principal | Aurelyn AI Clinical · Philadelphia, PA
🧪 Clinical AI Strategist 📊 Life Sciences Tech 🏛️ Regulatory Intelligence

I've spent my career at the intersection of clinical research and technology — watching brilliant teams struggle with the same preventable problems: drowning in documents, inconsistent data, audit anxiety, and a training gap that's widening every year. Aurelyn AI Clinical exists because that suffering is optional.

  • MSc. in Life Sciences & AI-driven research strategy
  • Founder of Aurelyn AI Clinical — AI strategy, SaaS & training for CROs, pharma & biotech
  • Creator of the Aurelyn Clinical Trial OS™ framework
  • Trainer to hundreds of clinical research professionals globally
Is This For You?

Who's In The Room Today

If you check even one of these, you're in exactly the right place.

🔬
CLINICAL RESEARCH ASSOCIATE
Buried in monitoring reports & TMF filing
📋
CLINICAL OPERATIONS MANAGER
Struggling to standardize across sites
⚖️
REGULATORY AFFAIRS PROFESSIONAL
Navigating ICH, FDA, EU AI Act simultaneously
🏢
CRO / BIOTECH EXECUTIVE
Needing efficiency without sacrificing compliance
📊
DATA MANAGER / BIOSTATISTICIAN
Spending hours on manual data cleaning
🎓
NEW CLINICAL RESEARCH PROFESSIONAL
Trying to stay ahead in a rapidly evolving field
The Burning Platform

Clinical Research in 2026: The Hard Numbers

90%
Clinical trials miss their primary endpoint — the global average
Tufts CSDD, 2024
$2.6B
Average cost to bring a new drug to market — a 15-year process
Deloitte Life Sciences, 2024
15 yrs
Average time from molecule discovery to patient access
FDA Innovation Data
68%
Of trials experience significant delays — most are preventable
GlobalData Clinical Reports
40%
Of audit findings are due to documentation & TMF issues
MHRA / FDA Form 483 Analysis
3×
More data generated per trial than just 5 years ago — systems can't keep up
Veeva Unified Clinical Ops Survey

These aren't just statistics. Behind every number is a delayed patient, a burned-out team, and a budget overrun.

Pain Point #1

The TMF Document Tsunami

A single Phase III trial generates 50,000–100,000+ documents. Most teams manage them in spreadsheets, shared drives, and email threads.

📁
FILING CHAOS
Documents misfiled, missing, or version-controlled by the honor system. Audit-readiness is a fantasy, not a fact.
⏰
TIME DRAIN
CRAs spend up to 40% of their time on TMF administration — time stolen from actual monitoring and patient safety.
🔍
INSPECTION RISK
Incomplete TMFs are the #1 trigger for FDA Form 483s and MHRA critical findings. One inspection can derail a trial.
🔄
REWORK LOOPS
Without intelligent classification, the same document gets re-filed, re-checked, and re-queried — over and over again.
"We had a full-time person just tracking what was missing from the TMF. That's not a process — that's a symptom."
— Clinical Operations Director, Top 20 CRO
Pain Point #2

The Consistency Crisis

Across sites, protocols, and teams — clinical data inconsistency is the silent trial killer.

📊 DATA ENTRY VARIATION
The same adverse event gets coded 5 different ways across 5 different sites. Statisticians spend weeks reconciling what should be automatic.
📝 PROTOCOL DEVIATIONS
Minor protocol deviations go undetected until a monitoring visit — sometimes months later. Each one is a potential regulatory finding.
🏥 SITE VARIABILITY
Site #1 and Site #12 use different forms, different abbreviations, different processes. Sponsors spend fortunes on harmonization — and still fail.
🔎 LATE DETECTION
Issues found at database lock cost 10× more to fix than if caught real-time. The industry is paying a massive tax on late discovery.

Inconsistency isn't a people problem — it's a systems problem. And AI is the system designed to solve it.

Pain Point #3

The Talent Gap & Training Crisis

The industry needs 280,000+ new clinical research professionals by 2028. The training infrastructure hasn't kept up.

  • ICH E6(R3) released — most teams haven't been trained
  • AI tools deployed before staff understand how to use them responsibly
  • New CRAs thrown into trials with minimal onboarding
  • Experienced staff leaving — and taking institutional knowledge with them
  • Academy-based training closes this gap at scale
  • AI-assisted learning accelerates competency 3× faster
62%
of clinical research professionals say their organization provides insufficient AI training
Aurelyn AI Clinical Survey, 2025
280K+
new qualified clinical research professionals needed globally by 2028
World Clinical Trials Report
3×
faster competency development with structured AI-assisted learning paths
L&D Research Consortium
The Bottom Line

The Real Cost of Doing Nothing

$500K
Average cost of a single critical FDA 483 finding for a mid-size sponsor
18 mo.
Average delay from a major TMF inspection finding to trial restart
31%
Of data integrity issues are directly attributed to inadequate staff training
"Every month a trial runs over schedule costs a sponsor $600,000 to $8 million in delayed revenue. Prevention is not a budget item — it's a business imperative."
— Clinical Operations Intelligence Report, 2025

The question is no longer "Can we afford AI?" — it's "Can we afford not to?"

The Turning Point

What If Your Clinical Team Had a
Genius Co-Pilot?

Imagine starting your Monday knowing that every TMF document is classified correctly. Every protocol deviation is caught in real-time. Every team member has training that's tailored to exactly where they are in their career.

🎯
PRECISION
AI that understands clinical context — not just keywords
⚡
SPEED
Documents classified in seconds, not hours
🛡️
CONFIDENCE
Regulatory alignment built into every workflow

This isn't science fiction. This is the Aurelyn AI Clinical Trial OS™.

Demystifying AI

What AI Actually Does in Clinical Research

No jargon. No hype. Just a plain-English explanation of what modern AI does — and what it doesn't replace.

✦ AI IS GOOD AT
  • Pattern recognition across millions of documents
  • Real-time consistency checking against protocols
  • Automated classification and tagging
  • Anomaly detection before it becomes a finding
  • Personalized learning recommendations at scale
  • Summarizing regulatory guidance into actionable steps
✗ AI DOES NOT REPLACE
  • Clinical judgment and medical expertise
  • Patient relationships and site rapport
  • Ethical decision-making and accountability
  • Your regulatory authority and professional credential
"AI doesn't replace the clinical researcher — it removes the noise so the researcher can do what only a human can do."
— Sheilah Johnson-Rocha, MSc.
The Solution

Introducing the Aurelyn
Clinical Trial OS™

A unified, AI-powered operating system purpose-built for clinical research — covering every layer of your operations.

CLINICAL
TRIAL OS™
📁
eTMF Intelligence Engine™
🧠
Evidence & Consistency Engine™
🎓
Clinical Academy™
🤝
AI Advisory Services™
Pillar 1 of 4

eTMF Intelligence Engine™

AI-powered TMF classification, completeness monitoring, and inspection-readiness — running 24/7 in the background.

📁
eTMF Intelligence Engine™
Autonomous document intelligence for Trial Master Files
Auto-classifies documents against the TMF Reference Model — no manual filing required
Real-time completeness dashboards: know your TMF health score at a glance
Intelligent version control that flags conflicts before they become findings
Inspection-readiness reports generated in minutes, not weeks
Missing document alerts before auditors arrive — proactive, not reactive
Full ICH E6(R3), 21 CFR Part 11, and EU AI Act alignment built in
💡 THE IMPACT
Teams using AI-assisted TMF management report 60–70% reduction in audit preparation time and a dramatic drop in critical inspection findings. One inspection cycle pays for years of the platform.
Pillar 2 of 4

Clinical Evidence & Consistency Engine™

Real-time data quality surveillance and cross-site harmonization — catching inconsistencies before they become protocol deviations.

🧠
Clinical Evidence & Consistency Engine™
Cross-site data quality intelligence and protocol surveillance
Continuous cross-site data consistency monitoring — 24/7 automated surveillance
Real-time protocol deviation detection with severity scoring and priority alerts
Intelligent data reconciliation that flags discrepancies before database lock
Natural-language clinical evidence summaries for regulatory submissions
ALCOA+ compliance monitoring with automated audit trail generation
Risk-based monitoring support aligned with FDA and ICH risk frameworks
💡 THE IMPACT
Organizations using real-time consistency engines report up to 45% fewer protocol deviations and cut data cleaning time by more than half — meaning faster database lock and faster submissions.
Pillar 3 of 4

Aurelyn Clinical Academy™

Structured, accredited AI education designed for clinical research professionals — from CRA to C-Suite.

🎓
Aurelyn Clinical Academy™
AI literacy and leadership training for the modern clinical workforce
8-module AI Governance Leadership Course — Bloom's taxonomy-aligned, certificate-bearing
Patient Recruitment & Engagement training — 8 interactive modules with scenario simulations
AI for Organizations — enterprise B2B tracks for teams of 10 to 10,000
Regulatory Intelligence updates: EU AI Act, ICH E6(R3), 21 CFR Part 11, NIST AI RMF
SCORM 1.2-compliant modules for LMS integration — plug into your existing systems
AI Readiness Assessments and personalized learning pathway generation
🏅 Certificate Programs 📱 Mobile-Optimized 📊 LMS Integration 🌍 Global Compliance
Pillar 4 of 4

AI Advisory Services™

Strategic guidance from experts who've lived in both worlds — clinical research and AI technology.

🤝
AI Advisory Services™
Strategic AI implementation and readiness consulting
AI Readiness Assessment — a 45-minute deep dive into your current operations + written report
Technology roadmap development: which AI tools to adopt, when, and in what order
Regulatory validation strategy for AI/ML tools under 21 CFR Part 11 and EU AI Act
Vendor evaluation frameworks — cut through the noise of a crowded marketplace
Change management support: getting your team from resistant to ready
Executive AI briefings and board-level strategy presentations
🎯 WHO THIS IS FOR
CROs, biotech and pharma sponsors, academic medical centers, and site management organizations who want to implement AI correctly the first time — not spend three years and seven figures learning the hard way.
Who Benefits

Who Wins With the Platform

🔬 CRAs & CLINICAL TEAMS
Stop spending half your day on administrative work. The engine handles classification, flagging, and completeness checks — you focus on monitoring quality and patient outcomes. Reclaim 40% of your operational hours.
📋 CLINICAL OPS MANAGERS
Get real-time visibility across all trials, all sites, all teams. Know before your monitor visit what issues are brewing. Present leadership with data-driven insights, not status reports built from email threads.
⚖️ REGULATORY AFFAIRS
Navigate the evolving regulatory landscape with confidence. Real-time alignment with ICH E6(R3), EU AI Act, 21 CFR Part 11, and NIST AI RMF — with documentation that proves it to any inspector.
🏢 EXECUTIVES & CROs
Deliver trials faster. Reduce the cost of quality. Differentiate your organization to sponsors with demonstrable AI capability. Win contracts that require proven digital excellence.

One platform. Every role. Every stage of the trial lifecycle.

Built for Compliance

Built for Regulatory Confidence

Every feature of the Aurelyn Clinical Trial OS™ is designed to align with — not circumvent — regulatory expectations.

REGULATION / FRAMEWORKWHAT IT COVERSHOW WE ALIGNSTATUS
ICH E6(R3)GCP guidelines for clinical trialsTMF completeness, risk-based monitoring, data integrity checks✓ Full Alignment
21 CFR Part 11FDA electronic records & signaturesAudit trails, e-signature workflows, access controls, validation docs✓ Full Alignment
EU AI Act (2026)AI system governance in regulated industriesTransparency documentation, human oversight, bias monitoring✓ Full Alignment
ALCOA+Data integrity principlesAutomated traceability, contemporaneous records, complete audit logs✓ Full Alignment
NIST AI RMFAI risk management frameworkRisk categorization, validation protocols, incident response workflows✓ Full Alignment
TMF Reference ModelIndustry standard TMF structureAuto-classification against 800+ document zones, artifacts, and metadata✓ Full Alignment

We don't add compliance as an afterthought. Regulatory alignment is the foundation everything else is built on.

Real Questions We Hear

Let's Address the Elephant in the Room

"Our team doesn't have any technical background — will they be able to use this?"+
Absolutely. The Aurelyn platform is designed for clinical researchers, not software engineers. If your team can file documents and write monitoring reports, they can use this. Our Clinical Academy onboarding has gotten non-technical CRAs proficient in under a week. We build the AI — you bring the clinical expertise.
"We already have a TMF system — why would we need this?"+
Most TMF systems store documents — they don't intelligently classify, monitor, or analyze them. Think of it like the difference between a filing cabinet and a chief of staff who reads everything and tells you what needs attention. We layer intelligence on top of what you already have, integrating with Veeva Vault, Investigator Portal, and other standard platforms.
"Can we trust AI to handle regulated clinical data?"+
This is the most important question — and the right one to ask. Our platform is built on validated, auditable AI with complete transparency. Every AI decision has an explainable rationale, a full audit trail, and a human override mechanism. We go through the same regulatory validation process your own QA team would apply to any clinical software. Trust is earned through evidence — and we bring it.
"We don't have budget for something new right now."+
I understand — and I'd ask you to do one calculation: what did your last FDA 483 cost? What does one delayed database lock cost per month? What does a 6-month trial delay cost in foregone revenue? When the math is done, the question usually becomes "Can we afford NOT to implement this?" We offer flexible pricing and a free AI Readiness Assessment to start.
"How long does implementation take?"+
Our modular approach means you can start with one pillar and expand. The eTMF Intelligence Engine can be configured and running in as little as 2 weeks for a single trial. Full platform onboarding for an enterprise CRO typically takes 60–90 days — including staff training, validation documentation, and integration testing.
Your Action Plan

Your 90-Day Path Forward

Whether you're brand new to AI or already exploring tools — here's a proven roadmap that works regardless of your starting point.

30
DAYS 1–30
ASSESS & ALIGN
  • Complete your AI Readiness Assessment
  • Identify your #1 operational pain point
  • Map your current TMF and data workflows
  • Enroll key team members in Clinical Academy
  • Set your first 30-day success metric
60
DAYS 31–60
PILOT & TRAIN
  • Launch eTMF Intelligence Engine on one trial
  • Complete first two Academy training modules
  • Establish your AI governance baseline policy
  • Run first AI-assisted audit-readiness check
  • Document early wins for stakeholder buy-in
90
DAYS 61–90
SCALE & LEAD
  • Expand to consistency monitoring across sites
  • Roll out AI training to full team
  • Present AI ROI report to leadership
  • Define year-two AI strategy roadmap
  • Position your org as an AI-capable partner

90 days from now, your team is either ahead of the curve or still filing manually. The choice is yours — starting today.

Exclusive Webinar Offers — Today Only

Your Next Step Starts Now

Three ways to move forward — pick the one that fits where you are right now.

🎯
OFFER 1 — FREE
AI Readiness Assessment
A 45-minute 1:1 strategy session with Sheilah + a personalized written AI readiness report — normally $450. Free for webinar attendees.
📧 Email subject:
AI Readiness Assessment
to support@aurelynai.com
MOST POPULAR
🎓
OFFER 2 — FREE
First Course Free
Get your first Aurelyn Clinical Academy course at no charge. Choose from AI Governance Leadership, Patient Recruitment, or AI for Organizations.
🔑 Promo code:
AIWEBINAR26
at aurelynai.com
📘
OFFER 3 — FREE
AI Clinical Research Playbook
The 2026 Edition of our comprehensive AI Clinical Research eGuidebook — covering all major regulatory frameworks, maturity models, and implementation strategies.
🌐 Download free at:
aurelynai.com

These offers are for webinar attendees only. They won't be available after today.

Aurelyn AI Clinical

Questions & Conversation

This is your time. Ask anything — about AI, about your specific situation, about the platform, or about how to get leadership buy-in at your organization.

🌐
EXPLORE
aurelynai.com
📧
CONNECT
support@aurelynai.com
🎓
CODE
AIWEBINAR26
"Clinical research is already hard enough. The technology exists today to make it smarter, faster, and safer. The only question is who leads the change — and whether that leader is you."
— Sheilah Johnson-Rocha, MSc. | Founder, Aurelyn AI Clinical

Thank you for being here. The future of clinical research is intelligent — and it starts now.