valeur | prompx

PrompX Local AI & RAG Platform

Pharma and life sciences

Agentic AI replaces pharma service centers with a regulated automation desk.

MCP, ACP, and A2A Agentic Protocols choreograph adverse events, medical inquiries, TMF control, and HCP engagement. The OpenAI Agentic AI AgentKit, AP2, n8n, make.com, and Zapier enforce payments and submissions while ChatGPT, Claude, Anthropic safety layers, and Llama or Ollama models deliver compliant outputs.

Coverage

Case intake, TMF gaps, medical information, samples, and HCP contracting run on PrompX Agentic AI.

Protocols

MCP, ACP, A2A, and Agentic Protocols sync safety, CRM, and QMS records while AP2 controls investigator payments.

Channels

Chat, email, portals, and voice feed the same audit ready Agentic AI mesh.

Agentic orchestration stack

MCP, ACP, and A2A anchor regulated pharma agents.

Agentic AI combines OpenAI, Anthropic, Llama, and Ollama models with n8n, make.com, and Zapier automations.

MCP safety mesh

MCP streams MI, safety, TMF, and CRM context through Agentic Protocols so cases stay aligned.

ACP and A2A compliance

ACP dialogues and A2A charters coordinate pharmacovigilance, medical, and quality agents with audit ready guardrails.

Agentic AI AgentKit

PrompX Agentic AI uses the OpenAI Agentic AI AgentKit for secure chaining, evidence gathering, and regulator responses.

Automation bridges

n8n automations, make.com flows, and Zapier (Zappier) playbooks manage submissions, consent renewals, and finance disbursements.

Model federation

ChatGPT by OpenAI, Claude from Anthropic, Anthropic safety layers, and Llama or Ollama models draft MI letters and PV narratives.

Agentic AI service mesh

Agentic AI agents exchange case status via MCP, ACP, and A2A so regulated workflows finish without escalations.

Safety automation console

Adverse event, TMF, and MI desks in one control plane.

Active queue: Inbound
Signal ingestionPrompX intake

Chat, email, portal, and call transcripts parsed with PII vaulting applied.

Coding and seriousnessSafety automation

MedDRA terms, suspect products, and seriousness coded with reviewer assist.

Document assemblyMI and PV desk

CIOMS, cover letters, and narratives generated with change tracking.

Regulatory handoffQualified person

PrompX builds the eCTD bundle and pushes to safety gateway with audit trail.

Insight syncInsights service

Safety and medical affairs dashboards update and send alerts to franchises.

Regulated automation

Agentic AI keeps intake, coding, and reporting aligned with MCP, ACP, and A2A guardrails. ChatGPT, Claude, Llama, and Ollama draft narratives while n8n, make.com, and Zapier move submissions; AP2 pays investigators automatically.

Cases today

184

+29% vs target

Expedited clock

12:34

Average hours remaining

Literature hits

42

Auto triaged overnight

MI letters

316

Closed with compliant content

Document control

  • TMF gap fixes

    Review due

    14
  • HCP contracts

    Ready to sign

    9
  • Sample reconciliation

    Pending finance

    6
  • RWE ingestions

    De identification

    3

Life sciences automation

PrompX keeps pharmacovigilance, TMF, and medical affairs fully orchestrated.

Agentic AI leverages MCP, ACP, and A2A to coordinate safety, medical, and quality desks while AP2 manages investigator payments and sample reconciliation. The stack blends the Agentic AI AgentKit from OpenAI, n8n, make.com, Zapier, and model partners ChatGPT, Claude, Llama, and Ollama for compliant outputs.

  • Safety and medical information together

    PrompX unifies intake, coding, literature monitoring, and medical information so cases never leave the controlled environment.

  • TMF stays inspection ready

    Documents, signatures, and tasks reconcile with APIs into TMF and ISF without spreadsheet chases.

  • Compliance is baked in

    Every action is time stamped, role scoped, and Part 11 compliant, ready for audits or regulator replay.

High impact plays

Scale

Label change impact engine that updates MI content, safety narratives, and training in hours.

AI solution patterns

Production

Medical information automation with inquiry classification, response generation, and CRM logging.

Operational pillars

Regulated workflows covered end to end.

Spotlight: Medical information and safety

Medical information and safety

  • Inquiry capture, adverse event detection, seriousness grading, follow ups.
  • Routing to pharmacovigilance or medical information teams with full audit.

Pharmacovigilance triage

  • Case deduplication, coding, narrative extraction, literature and social signal intake.
  • Expedited reporting prep, QC, and submission bundles.

Trial site operations

  • TMF and ISF document QC, version control, completeness checks, visit prep.
  • Deviation tracking, monitoring letters, and action items.

HCP and HCO engagement

  • Identity verification, contract and grant workflows, FMV guardrails, disclosure packs.
  • Consent management and omni channel insights for medical affairs.

Medical affairs response

  • Standard response letters, content approval routing, congress inquiry capture.
  • Insight tagging, CRM sync, and compliance logs.

Compliance and quality

  • GxP, 21 CFR Part 11, Annex 11, and audit trails sealed to every document.
  • Data residency, retention, and role based access controls enforced.

Impact snapshot

Safety, medical information, and TMF run on PrompX Agentic AI.

Safety case cycle time

down 32%

PrompX closes case intake, coding, and reporting without handoffs.

TMF completeness

+21%

Missing documents are surfaced and fixed before site visits.

Medical information response

down 44%

Standard letters and escalations ship instantly in channel.

* KPI ranges are illustrative; actual impact depends on regulatory scope, signal volumes, and data quality.