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ENVERALIGN AI™
Microsoft Word Native • 21 CFR Part 11 Aligned

AI Embedded for Speed.
Grounded in Clinical Truth.

The zero-hallucination agentic writing suite embedded natively inside desktop Microsoft Word. Linking draft narrative claims directly to immutable Clinical Study Report (CSR) coordinates and federated registries.

Enveralign AI™ • Native Word Taskpane Walkthrough
1:13 Run Time

The Biopharma Bottleneck

Why Ungoverned Generative AI Fails Clinical Publication

Medical writing demands absolute statistical precision. Ungoverned LLMs introduce hallucination and compliance risks regulated teams cannot accept.

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Generative Hallucination

Standard AI fabricates patient numbers, confidence intervals, and trial endpoints. In clinical regulatory writing, a single invented statistic disqualifies the entire asset.

Enveralign: 100% [p. X, Line Y] Deterministic Grounding
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Copy-Paste Context Loss

Writers lose hours toggling between massive 1,000-page CSR PDFs, external web tools, and separate bibliography software—introducing friction and manual error traps.

Enveralign: Native MS Word Embedded Workspace
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Compliance & Governance Void

Consumer AI tools lack verifiable audit trails, breach ICMJE authorship guidelines, and risk leaking sensitive, unpublished clinical trial data into shared model pools.

Enveralign: 21 CFR Part 11 Audit Trail & ZDR

Clinical Application Layer

Active Clinical Workflows

Purpose-built modules integrated natively into desktop Microsoft Word for Medical Affairs and Regulatory teams.

✍️ Enveralign Drafter

Available in Pilot

Accelerates CSR-to-manuscript transformations, section summaries, and structured outlines while preserving rigorous medical narrative coherence.

Senior Medical Writers Powered by Enveralign AI™

🛡️ Enveralign Audit

Available in Pilot

Deterministic reference checking, live registry concordance auditing, and ICMJE author compliance verification inside active Word documents.

QC Editors & Authors Powered by Enveralign AI™

Looking for Protocol-to-CSR validation or congress intelligence? Inquire about our upcoming co-development tracks.

Underlying Core Engine

Enveralign AI™ Engine Infrastructure

Deterministic coordinate extraction engines and cryptographic audit pipelines powering every application.

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MS Word Co-Location

Zero context switching. Authors draft, redline, and inspect sources directly within desktop Word through an integrated sidebar interface.

M365 Enterprise Ready
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[p. X, Line Y] Provenance

100% deterministic coordinate anchors. Every extracted statistic binds to exact CSR PDF line items and tables.

Zero Hallucinations
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Federated Audit

Asynchronous live PubMed (PMID), CrossRef (DOI), and ClinicalTrials.gov (NCT) validation with deterministic metadata concordance.

NEJM • Lancet • JCO
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Enterprise Isolation

Dedicated virtual private cloud deployment, customer-managed encryption keys (CMEK), and automated zero-retention data pipelines.

Zero Data Retention (ZDR)
HITL

Human-in-the-Loop by Design • ICMJE Compliant

AI never publishes or commits unilaterally. Enveralign AI acts exclusively as an assistive agent—extracting, redlining, and auditing—while human medical authors retain 100% editorial authority, final sign-off, and accountability backed by an immutable 21 CFR Part 11 audit trail.

Lorenzo Lacey, MBA

Lorenzo Lacey, MBA

Founder & CEO, Enveralign, Inc.

• Former Global Digital Leader, AstraZeneca
• Principal, EL Castello Business Advisors
• BSEE | MBA
• MIT Sloan Executive Education (Agentic AI)
Cherry Hill, NJ • Greater Philadelphia Area
Leadership & Vision

Why We Built Enveralign

Having spent nearly two decades in Big Pharma scaling global digital delivery and commercial portfolios, I have experienced firsthand the cost of clinical publishing delays. In regulatory and scientific writing, standard AI tools fail because medical communication requires 100% statistical precision, a single hallucinated data point invalidates an entire manuscript.

We founded Enveralign to solve this exact bottleneck. By pairing deterministic, zero-hallucination coordinate extraction with human-in-the-loop scientific oversight, we accelerate how clinical discoveries transition into published literature and transparent disclosures natively, inside desktop Microsoft Word.

"Our mission is to arm life sciences leaders with autonomous intelligence that respects regulatory rigor, ensuring life-changing medicines reach patients faster."

Lorenzo Lacey, MBA

Founder & CEO, Enveralign, Inc.

Connect with Lorenzo

14-Day Design Partner Pilot Program

Deploy to 1–2 senior medical writing editors. Benchmark QC velocity across active clinical trial drafts against source CSRs.