Pharmelyx AI is the operating platform for pharmaceutical consulting and regulatory strategy. It unifies sponsor RFP intake, clinical study report extraction, regulatory gap analysis, and risk-adjusted scenario modeling. AI traces every recommendation back to exact trial coordinates, reconciling conflicting study endpoints and producing defensible, client-ready advisory deliverables.
91.4% evidence completeness across the HTX-214 dossier — AI forecasting projects reaching 96.0% upon closing open regulatory gaps.
140+ hrs
saved per engagement
3.8×
faster delivery speed
75%
manual review reduced
2.5×
client engagement scale
Care moves differently in every clinical setting, with unique practitioner workflows, client journeys, notes, and documentation standards. Explore our purpose-built AI platforms designed for each care vertical.
Pharmelyx AI unites the complete pharmaceutical advisory lifecycle from initial sponsor qualification to final engagement closure: Intake Pipeline, Document Intelligence, Evidence Review, Development Planning, Advisory Delivery, and Engagement Closure. Every module preserves exact trial coordinates, audit trails, and authorized expert review gates.
Capture and qualify incoming sponsor requests across therapeutic areas and modalities. Layout-aware AI parses study documents, extracts objectives, and baselines consulting deliverables before initial kickoff calls.
Ingest complex clinical study reports, investigator brochures, and eCTD sequences in seconds. Layout-aware AI isolates primary endpoints, patient cohorts, and confidence intervals with exact coordinate grounding.
Cross-verify clinical evidence across study protocols, CSR synopses, and statistical plans. Identifies denominator mismatches between ITT and Per-Protocol cohorts before conflicting values reach client deliverables.
Model dynamic development roadmaps comparing Base, Accelerated, and Conservative pathways with live recalculation. Intelligent dependency tracking projects schedule variance and risk-adjusted NPV for milestone decisions.
Author high-stakes regulatory strategy deliverables, briefing books, and target product profiles. Continuously validates citations against active dossier sources and blocks unsupported claims before client release.
Guide engagements through client sign-offs, milestone invoice reconciliation, and controlled audit archiving. Automated checklists enforce 21 CFR Part 11 retention policies, locking all verified records in one repository.
Capture and qualify incoming sponsor requests across therapeutic areas and modalities. Layout-aware AI parses study documents, extracts objectives, and baselines consulting deliverables before initial kickoff calls.
Ingest complex clinical study reports, investigator brochures, and eCTD sequences in seconds. Layout-aware AI isolates primary endpoints, patient cohorts, and confidence intervals with exact coordinate grounding.
Cross-verify clinical evidence across study protocols, CSR synopses, and statistical plans. Identifies denominator mismatches between ITT and Per-Protocol cohorts before conflicting values reach client deliverables.
Model dynamic development roadmaps comparing Base, Accelerated, and Conservative pathways with live recalculation. Intelligent dependency tracking projects schedule variance and risk-adjusted NPV for milestone decisions.
Author high-stakes regulatory strategy deliverables, briefing books, and target product profiles. Continuously validates citations against active dossier sources and blocks unsupported claims before client release.
Guide engagements through client sign-offs, milestone invoice reconciliation, and controlled audit archiving. Automated checklists enforce 21 CFR Part 11 retention policies, locking all verified records in one repository.
Generic chatbots hallucinate citations and flatten clinical context. Pharmelyx AI puts a regulated orchestration layer between your advisory workflow and domain models, ensuring every clinical claim is verified against authentic source coordinates.
Manual PDF reading, conflicting population denominators, and unverified AI summaries.
Audits stall on missing source provenance.
Layout-aware document OCR captures study synopses, complex statistical tables, and footnotes with exact bounding box coordinates—never flattening clinical tables into raw unformatted text.
Extracts ORR, PFS, HR, and 95% CIs while binding every single data point to its exact page coordinates, study population (ITT vs PP), and document version date.
Detects numerical discrepancies across documents—flagging when an executive synopsis (62% ORR) cites a different analysis denominator than the audited CSR (58.2%, N=146).
Compares sponsor clinical packages against jurisdiction-specific FDA (21 CFR 312/314) and EMA (ICH M4/M8) requirements, scoring submission readiness with live citations.
Simulates accelerated vs conservative clinical trial timelines, calculating budget impact, PERT duration, and risk-adjusted NPV inside private sponsor tenant boundaries.
Compiles briefing books and strategic decision memos where every material scientific claim links directly to verified source coordinates and expert reviewer approval.
Note: Model names and marks are the property of their owners and appear here to say which APIs a workflow step can be routed to. No endorsement or partnership is implied.
Ingest sponsor RFPs, NDAs, and clinical dossiers. Multi-modal AI indexes CSRs, investigator brochures, and agency correspondence, creating a controlled evidence inventory with source coordinates and version locking.
Reconcile clinical study endpoints (ORR, PFS, HR), detect population denominator conflicts, and evaluate submission packages against jurisdiction-specific FDA and EMA requirements to surface actionable gap cards.
Model development scenarios, simulate PERT timelines and rNPV, and generate audit-ready briefing packages and decision memos where every material statement carries verified source provenance.
A pharmaceutical advisory practice is answerable for the trial evidence it evaluates, the regulatory requirements it cites, and the data integrity of its client deliverables. Pharmelyx AI is built to support the governing regulatory frameworks below, embedding audit-ready provenance directly into your workflow.
Enforces immutable audit trails, access controls, authority checks, and validated electronic signature workflows across all approved advisory deliverables.
Governs data lineage, version governance, and risk-based clinical evidence assessments to ensure trial integrity and regulatory audit readiness.
Validates submission-ready dossier structures across CTD Modules 1–5, XML message schemas, and cross-jurisdictional agency technical criteria.
Ensures comprehensive computerized system validation, automated security, data integrity, and formal change control for life sciences advisory operations.
Applies risk-based lifecycle methodologies to verify extraction algorithms, deterministic calculations, and source-grounded model evaluation.
Standardizes development requirements for Investigational New Drug (IND) filings and New Drug Applications (NDA) across FDA and global health authorities.
Note: These are standards the platform is built to support inside your workflows — obligations that fall on you as the licensee. They are not certifications held by us, and support in the product is not a substitute for your own counsel or compliance officer.
Validated clinical and endpoint capture hardware configured for your advisory and trial workflows. Each one feeds a module in Pharmelyx AI, streaming telemetry and evidence directly into your regulatory operating environment.
Medical-grade Bluetooth arterial and vitals monitor for decentralized clinical trial cohorts. Streams structured telemetry directly into Module 03 (Evidence Review) without manual transcription.
Continuous biometric band capturing participant mobility, circadian rhythms, and resting heart rates. Syncs real-world evidence logs into Module 04 (Development Planning) for protocol safety analyses.
Validated fingertip sensor streaming real-time blood-oxygen saturation and pulse data over BLE. Fully integrated into Module 02 (Document Intelligence) with 21 CFR Part 11 compliant audit trails.
A first walkthrough is a discovery of your advisory workflow. From there it is one plan at one price, giving your practice full access to all eight operational modules of Pharmelyx AI. No complex per-seat tiers to decode.
AI API usage is charged separately. Clients must recharge their AI credit balance based on their usage.
Starting at $200/mo — every module, every practitioner, billed monthly.
AI API usage is charged separately. Clients must recharge their AI credit balance based on their usage.
Nothing is locked in. Move at the pace your practice moves — change or pause whenever it suits you.
A one-time setup that gets your practice fully live before your first monthly cycle — we import your client records and appointment history, connect the calendar, intake and messaging you already run on, and tune every Pharmelyx AI module to the way your practitioners actually work.
Two ways to run Pharmelyx AI — same platform, same monthly subscription. Only the onboarding may differ by your requirements.
Pharmelyx AI is structured as a transparent, predictable practice subscription starting at our base monthly rate, with zero per-seat licensing penalties. Your entire cross-functional practice—managing partners, regulatory strategists, medical writers, and biostatisticians—can collaborate across unlimited sponsor projects. Heavy AI document ingestion and multimodal OCR are metered via clear, reloadable usage credits, ensuring you only pay for the exact volume of dossier pages and trial datasets your engagements require.
We believe enterprise software should prove its value on every billable milestone. All standard subscriptions operate on flexible month-to-month billing with no required multi-year lock-ins or cancellation penalties. If a major sponsor engagement concludes or your advisory pipeline shifts, you can scale your tier or export complete, 21 CFR Part 11-compliant audit archives and evidence manifests at any time.
Yes, unconditionally. We enforce bank-grade cryptographic multi-tenant isolation and strict zero-retention policies. Your sponsors' confidential clinical trial protocols, Investigator's Brochures, CSRs, and CMC files are never used to train public or foundational models, and never enter a shared retrieval index. Everything remains strictly isolated within your private practice tenant under rigorous enterprise BAA, NDA, and SOC 2 Type II controls.
Yes. Unlike generic chatbots that hallucinate citations, every data point extracted by Pharmelyx AI retains immutable source provenance, exact PDF coordinate bounding boxes, and timestamped audit logs. Role-based access controls and dual-authorization review gates ensure no AI-generated regulatory finding or strategic deliverable reaches a client sponsor without authorized expert sign-off.
Most life sciences advisory practices see immediate margin expansion within their very first active engagement. By automating layout-aware CSR endpoint extraction, population reconciliation (ITT vs. Per-Protocol), and CTD gap detection, consulting teams reduce manual evidence gathering time by up to 70%. Senior partners can review 3x more deliverables while junior consultants eliminate hundreds of unbilled hours spent re-checking spreadsheet data.
In competitive pitches, pharmaceutical sponsors look for speed, transparency, and defensibility. Providing an interactive, source-grounded evidence graph—where every strategic recommendation links directly to verified trial page coordinates and jurisdiction-specific FDA/EMA guidelines—instantly sets your firm apart from legacy consultancies delivering static slide decks and ungrounded summaries.
Your practice can be fully operational in under 14 days. Our dedicated Life Sciences Concierge team manages full technical onboarding: configuring your custom advisory deliverable templates (Target Product Profiles, Type B Briefing Books, Regulatory Gap Registers), connecting your secure document repositories, and running hands-on workshops with your consultants using reference oncology and rare-disease datasets.
Every subscription includes dedicated account management, a 99.9% uptime SLA, and direct communication via private Slack or Teams channels. Furthermore, our dedicated regulatory intelligence team continuously updates our jurisdiction rule packs—monitoring effective dates for FDA eCTD v4.0, ICH E6(R3), and EMA guidelines—so your strategic advice remains current with global health authority enforcement.
Evaluating Pharmelyx AI for an upcoming sponsor engagement or practice-wide rollout? Speak with our advisory team — we’ll walk through custom scope, security validation, and ROI modeling.
Pinned to its one relevant industry playbook, and connected through the documented APIs of the tools your practice already runs on.
discover nestack agentsNote: Tool names and marks belong to their respective owners. No endorsement or partnership implied. Integration availability depends on your existing systems, licences, API access and implementation scope.
