Osiris Inc · Medical Affairs Operations

$2M AI Integration Program

A governed Medical Affairs AI operating system: one evidence core, eight funded workstreams, and measurable workflow improvements across inquiry response, evidence intelligence, field insights, content, analytics, compliance and adoption.

$2.0M

Total program budget

18–24

Month transformation

Initiative deep dives

Operating model

From reactive support to governed evidence intelligence

Reactive support

Manual request handling
Periodic literature scans
Field insights dispersed
Content cycles measured in weeks

AI-enabled intelligence

RAG evidence retrieval
Continuous signal monitoring
MSL insight aggregation
Human-reviewed content factory

Design principle: a shared governed platform should power multiple Medical Affairs workflows rather than separate point tools.

Budget portfolio

How the $2.0M is allocated

Initiative	Budget
Enterprise Medical Affairs AI Platform	$650K
Medical Information AI Assistant	$300K
Scientific Literature Intelligence Engine	$250K
MSL Copilot & Field Insights Platform	$250K
Medical Content Generation Factory	$200K
Real-World Evidence & Publication Analytics	$150K
Data Governance, Validation & Compliance	$100K
Training & Change Management	$100K
Total	$2.0M

$650K

Platform

$700K

Workflow AI

$350K

Evidence analytics

$200K

Governance + training (control pool)

Platform architecture

One governed core links sources, validation, RAG and outputs

Sources

Medical information DBs Publications / PubMed Congress materials SOPs / review content Trial summaries / SRLs

Governed Medical Affairs AI core

✓ Approved knowledge repository
✓ RAG with cited evidence retrieval
✓ Prompt governance & output controls
✓ Audit trails & validation evidence
✓ Role-based access by workflow

Outputs

Medical Information drafts Literature alerts MSL pre/post-call support Content generation requests RWE / publication dashboards

Compliance intent: every generated output is source-grounded, permissioned, logged, and routed through the right human review path.

18–24 month roadmap

Scale only after platform and governance gates are in place

0–6 mo · Foundation

Secure environment
Knowledge repository
GxP assessment
Leader alignment

6–12 mo · Pilot

MI assistant MVP
Literature engine
Validation protocols
Role training

12–18 mo · Scale

MSL / content rollout
RAG expansion
Audit evidence
AI certification

18–24 mo · Executive intel

RWE analytics
Command center hooks
Governance board
Standardized use

Stage gate: do not broadly scale content generation or field insight automation until validation, audit logging and human-review workflows are accepted.

Initiative deep dives

Eight funded workstreams

1 · Enterprise Medical Affairs AI Platform

$650K

The shared control plane: reusable AI environment, approved knowledge layer, access controls and validation documentation.

Capabilities: RAG · scientific Q&A · automated evidence retrieval · compliance-controlled outputs. Deliverables: private GPT · approved repository · role-based access · validation docs. Dependencies: data source inventory · content ownership model · legal/compliance signoff.

2 · Medical Information AI Assistant

$300K

Automates intake-to-draft: intake → triage & duplicate detection → retrieve → draft with citations → escalate → human approve.

Impact: 50–70% expected reduction in response drafting effort. A medical reviewer remains accountable for the final scientific response.

3 · Scientific Literature Intelligence Engine

$250K

Continuous monitoring of PubMed, congress abstracts, competitor publications, guidelines and safety updates → summarized signals.

Feed: monthly landscape report · KOL alerts · competitor movement · safety-signal watchlist.

4 · MSL Copilot & Field Insights Platform

$250K

Pre-call briefings, in-call prompts & capture, post-call notes and insight extraction — aggregated into a field insights lake by TA, region, topic and competitor.

Impact: a searchable scientific intelligence network for Medical Affairs leadership.

5 · Medical Content Generation Factory

$200K

Request → AI-assisted draft → medical/legal/compliance review → publish → reuse. Mandatory human review is the release gate.

Types: slide decks · scientific narratives · congress summaries · newsletters · training. Benefit: weeks → days.

6 · Real-World Evidence & Publication Analytics

$150K

Evidence heat maps, publication gaps, investigator trends and emerging themes → planning recommendations.

Decisions: where evidence is thin · which investigators are emerging · which topics deserve funding.

7 · Data Governance, Validation & Compliance

$100K

GxP assessment & risk classification, AI validation protocols, hallucination testing, prompt governance, audit logging, legal/compliance review.

Principle: AI outputs should be reviewable, testable, logged and governed before they become standard work.

8 · Training & Change Management

$100K

Awareness → prompt-engineering workshops → MI/MSL role training → Medical Affairs AI certification → governed recurring use.

Goal: move from experimentation to standardized use with clear ownership and review expectations.

Executive KPIs

Measure cycle-time, evidence, adoption and control

Outcome domain	Representative KPI	Workstreams
Efficiency	Inquiry draft effort reduction; content cycle weeks → days	MI Assistant, Content Factory
Evidence intelligence	Monthly landscape cadence; KOL & competitor alerts	Literature Engine, MSL Copilot, RWE
Field effectiveness	Pre-call brief usage; post-call insight extraction; themes by region/topic	MSL Copilot
Control maturity	Validation completion, hallucination testing, audit-log coverage, review compliance	Platform, Governance
Adoption	Certification completion, active users by role, standardized workflow use	Training, all workflows

Business-case framing: do not overclaim ROI; show measurable operational improvement, better scientific intelligence and stronger compliance evidence.

Premium add-ons

Executive-visibility modules, layered after the core

AI Medical Affairs Command Center

Large-screen hub for scientific activity, KOL engagement, publications, congress intelligence, inquiry volumes and safety signals.

$300K–500K

Custom Medical Affairs Foundation Model

Fine-tuned on historical inquiries, internal content, TA literature and approved communications.

$500K–1M

Digital KOL Twin Platform

Knowledge maps of experts: research interests, publications, congress activity, networks and influence trends.

$250K–400K

Sequence: fund the core first; add premium modules only once governance, repositories and high-value workflows are working.

90-day launch

Lock scope, controls, pilots and leadership cadence

Launch checklist

→ Confirm repositories, owners and source priority
→ Define validation and audit requirements
→ Select MI Assistant and Literature Engine as early pilots
→ Set KPI baseline for cycle time, quality, adoption and controls
→ Confirm governance board and escalation cadence

Decision gates

Platform — can one core support all workstreams?
Compliance — are validation, logs and review gates accepted?
Adoption — are role owners committed to standard workflows?
Visibility — is a command center worth funding after core proof?

Recommended start: platform + governance foundation, then Medical Information and literature intelligence pilots, then MSL/content/RWE scale.

Version 1 homepage

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Demo access