Medical Affairs Intelligence Platform

Strategic intelligence, built for Medical Affairs

One natural-language brief → 60+ pages of board-ready Medical Affairs strategy in a single session. Not a chatbot. Not a search tool.

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Live session output

HIV Portugal — Competitive Landscape

Strategic analysis covering market access, KOL mapping, regulatory status across 12 agencies, and evidence positioning — generated from 142 live sources in a single session.

PubMed ClinicalTrials.gov EU CTIS WHO ICTRP FDA EMA NICE HAS G-BA ANVISA COFEPRIS INVIMA PMDA NMPA PubMed ClinicalTrials.gov EU CTIS WHO ICTRP FDA EMA NICE HAS G-BA ANVISA COFEPRIS INVIMA PMDA NMPA

What It Does

One session. Not six weeks.

A single session can produce 60+ pages of structured strategic output — congress strategies, stakeholder maps, tactical matrices, compliance-ready Q&A frameworks — in a fraction of the time and cost of a traditional consulting engagement.

Competitive landscape analysis

Pipeline tracking, evidence mapping, and competitive positioning across therapeutic areas. A similarity engine identifies strategic parallels between compounds, mechanisms, and market dynamics.

Evidence synthesis

Structured analysis across clinical trials, publications, congress abstracts, and regulatory filings — with full citations. Extracts endpoints, hazard ratios, and p-values directly from source data.

One session, five deliverables

Strategic Summary for leadership, Operational Handbook for field teams, Medical Writer Handoff, Compliance Extract with evidence grading, and MSL Field Guide — all traceable to the same evidence base, restructured for each audience.

Key Detail

Competitive Intelligence

Tracks pipelines across all development phases, maps evidence gaps, and positions compounds against competitors using a proprietary similarity engine that scores mechanism overlap, indication coverage, and market positioning.

Pipeline Similarity Engine Market Dynamics

Transformation

The old way vs. sAÏmone

Medical Affairs teams are stuck in a manual loop — months of consultant cycles, static documents, siloed workstreams. sAÏmone replaces the loop with a structured intelligence layer.

Before

With sAÏmone

External strategy consultants

→ In-house AI-powered strategic planning

6–12 week engagement cycles

→ Single-session structured delivery

Manual briefing rewriting for every audience

→ Automated audience-specific reports

Static planning documents

→ Living plans with persistent memory

Generic news monitoring

→ Plan-specific impact assessments

Cross-functional alignment meetings

→ Integrated workstream delegation

Single-session delivery

What used to take 6–12 weeks of consultant engagement is delivered in one structured session — with full evidence traceability.

Five deliverables, one evidence base

Strategic Summary, Operational Handbook, Medical Writer Handoff, Compliance Extract, and MSL Field Guide — distilled, not regenerated.

Persistent orchestration

Plans live, sleep, and wake up. Programmes go dormant for weeks and reactivate with full strategic memory intact.

"The gap between what Medical Affairs needs and what manual processes can deliver is widening every quarter."

How It Works

An agent, not a search bar

sAÏmone runs a structured, multi-phase analysis pipeline. It researches, cross-references, validates, and produces — rather than waiting for you to prompt each step.

001

Phased MAPS Workflow

Follows a five-phase Medical Affairs Plan of Strategies methodology: context enrichment, landscape analysis, strategic assessment, tactical recommendations, and execution planning.

002

Live Data Integration

Queries PubMed, ClinicalTrials.gov, EU CTIS, WHO ICTRP, FDA, EMA, NICE, and regional registries across LATAM and Asia-Pacific. MeSH term expansion ensures comprehensive retrieval — nothing relevant is missed because of phrasing.

003

Session Manager

Persistent session architecture. Tracks context, manages deliverable state, and coordinates multi-agent workflows across extended runs.

004

Monte Carlo Simulation

Probabilistic scenario modelling for regulatory timelines and competitive launch sequences. Quantifies uncertainty across thousands of simulations.

005

Desktop-Native, Data-Sovereign

A native desktop application with local session storage. Your data stays on your machine. GDPR-compliant by architecture. Exports directly to Word and PDF.

006

Compliance Built In

Every output includes source citations, confidence qualifiers, and a compliance footer. Regulatory claims are validated against source agencies.

Context

Enrichment

Landscape

Analysis

Strategic

Assessment

Tactical

Recommendations

Execution

Planning

Architecture

Neuro-symbolic reasoning, not prompt engineering

sAÏmone is not a language model with a clever prompt. It is a scaffolded architecture: a neural substrate composed with an inspectable symbolic knowledge base — authored taxonomies, cascade contracts, and domain ontologies that enter as authoritative inputs before generation and as deterministic verification after it. Constraint is distributed across how the system is built, not collapsed into a single filter.

Symbolic knowledge architecture

At the core of sAÏmone sits a structured knowledge base encoding pharmaceutical Medical Affairs domain logic: strategic pillars, tactical taxonomies, stakeholder profiles, evidence hierarchies, and metric definitions — all with explicit interdependencies, constraint rules, and feasibility gates. Authored, validated, and deterministic.

Cascade contracts & decision space

Cascade contracts link stakeholder scope, tactical proposals, strategic pillars, and evidence tiers into a coherent decision space the substrate reasons within. Stakeholder access shapes which tactics are in play; tactical proposals hold consistency with their parent pillars; claims are bounded by the tier of evidence that supports them. These are authoritative inputs the model is trained to respect — a shaped, inspectable envelope rather than a single chokepoint — which is what keeps the reasoning navigable, domain-appropriate, and defensible.

Evidence epistemology

Every data point carries an explicit verification status: verified against primary sources, inferred from validated data, or flagged for internal confirmation. A four-tier evidence hierarchy governs what each source is allowed to claim — peer-reviewed publications support outcome-level claims; preprints are limited to activity-level observations.

Computational strategy layer

Beyond qualitative frameworks, sAÏmone runs live quantitative analysis within sessions: Monte Carlo simulations for regulatory timeline uncertainty, game-theoretic modelling for competitive scenarios, and decision-theoretic reasoning under incomplete information. Executable computational models, not summaries of theory.

How It Works

The Scaffolded Architecture

The neural substrate contributes contextual interpretation, flexible articulation, and reasoning across natural language. The symbolic scaffolding contributes authoritative ground truth, taxonomic structure, evidence tiering, and inspectable domain specification. Each becomes effective through the other: scaffolding directs the model at input; deterministic code verifies its claims at output. The composition produces domain-appropriate behaviour that neither layer alone could produce.

Compositional Inspectable Distributed Constraint

MAPS-Aligned KPIs

Strategic Pillars

Stakeholder Profiles

Evidence Tiers

Therapeutic Areas

Tested across diverse indications

sAÏmone's analysis pipeline is therapy-agnostic — it adapts to the indication based on the data it retrieves.

GLP-1 Agonists

Metabolic / Cardiovascular

ADC Oncology

Solid Tumours

HIV

Infectious Disease

NMIBC

Uro-oncology

Atopic Dermatitis

Dermatology / Immunology

Myasthenia Gravis

Rare Disease — Neurology

SMA

Rare Disease — Neurology

Alzheimer's

Neurology

+ More

Therapy-agnostic by design

Sample Outputs

What a session produces

Representative excerpts from real sAÏmone sessions. Each output is generated from live data, structured by the MAPS workflow, and exported with full citations.

HIV Portugal — Competitive Landscape

Market access, KOL mapping, regulatory status, and evidence positioning across 12 agencies

Competitive Intelligence Snapshot

EU-authorised product comparison with modality, regulatory status, and reimbursement by country

Evidence Gap-to-Action Analysis

Evidence gaps mapped to PCIPO priorities with specific Medical Affairs actions for each gap

Expanded Study Narrative

Live-validated context, master narrative, quality checklist, and compliance grading

Strategic Computation Layer

Decision-theoretic analysis with assumptions, confidence qualifiers, and inter-model sandbox

Portugal / EU — Regulatory Considerations

Regulatory access context, reimbursement verification, and data limitations flagged with audit URLs

Monte Carlo Simulation Engine

Live computational analysis modelling uncertainty across thousands of scenario iterations

Session Manager

Persistent session architecture — context tracking and multi-agent workflow coordination

It doesn't replace the chess player. It clears the board so they can see further.

Contact

Let's talk

sAÏmone is currently available through direct engagements with Medical Affairs teams. We're happy to walk you through the platform and what it produces.

Whether you're exploring AI tools for Medical Affairs, looking to improve your competitive intelligence workflow, or simply want to see a demo — we'd welcome the conversation.

saimone.avti@gmail.com