AugmentX

Your expertise,augmented and amplifiedby AI.

AugmentX is a validated AI platform for life sciences teams. It does the heavy lifting, keeps the work transparent, and lets your experts move faster with confidence.

Why AugmentX

Most AI Stops at the Answer. Regulated Work Starts There.

Bring your data, documents, and systems together. Put AI to work on the research, analysis, and first drafts. Your experts stay in control of every decision.

Other AI tools

They find and summarize, then hand the hard part back to you. No record of how they got there.

AugmentX

It connects, reasons, and checks. The decision and its evidence arrive together. Defensible from day one.

Your AI gives you an answer. Who stands behind it?

Explainability

Every output shows its reasoning and links back to the source. Your team defends the call, not just the result.

The documents are right there. Decisions still take too long.

Analysis

AugmentX pulls your documents, systems, and know-how into one layer. You move from information to decision without the grind.

The automation runs. But it runs without your experts.

Control

It works under the people who own the outcome. Full visibility. Human sign-off. No black box.

Domain Intelligence Suites

Purpose-Built AI for Life Sciences Workflows

Each suite runs on the AugmentX knowledge engine, turning a domain workflow into an AI-augmented, human-governed system that fits the way your teams already work.

AugmentX-PV

Pharmacovigilance and Safety Intelligence

Speed up safety review, signal detection, and surveillance reporting with AI-assisted analysis of your clinical and safety data. AugmentX-PV unifies case narratives, surveillance reports, and clinical datasets in one intelligence layer, with full traceability and human oversight at every step.

Primary users: PV Scientists, Case Reviewers, Safety Physicians, Signal Managers.

Core workflows

Surveillance report generationSignal detection and trend analysisAggregate safety reportsClinical data analysisSafety dashboardsLine listings

Key benefits

  • Faster safety reviews and reporting
  • More accurate signal detection
  • Less manual reconciliation
  • Traceable, evidence-backed outputs
  • Stronger regulatory confidence

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Dashboard

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Narrative

AugmentX-CSV

Validation and Compliance Intelligence

Streamline validation, SOP lifecycle management, and compliance documentation with AI-assisted drafting, analysis, and review. AugmentX-CSV improves inspection readiness while taking the manual effort out of regulated documentation.

Primary users: Validation Engineers, QA Leads, CSV Specialists, Compliance Writers.

Core workflows

SOP drafting and updatesPeriodic reviewsAudit log analysisInvestigations and CAPA supportValidation documentation and VSR generation

Key benefits

  • Less documentation effort
  • Faster validation cycles
  • Improved audit readiness
  • Greater consistency across records
  • Strong governance and traceability

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Periodic Review

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Findings

AugmentX-Custom

Tailored Knowledge and AI Solutions

Design domain-specific AI workflows across Quality, Clinical, Regulatory, and Scientific functions, built on your own data, SOPs, and expertise. AugmentX-Custom extends AugmentX into your environment with configurable agents and governed workflows that reflect how you actually work.

Application areas: Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Writing, Scientific Research.

A custom framework that is validated, structured, and GxP-ready

  1. 01Scope and DiscoveryMap the systems, documents, workflows, and governance needs.
  2. 02Agent DesignConfigure workflows, skills, and approval logic aligned to your SOPs.
  3. 03Sandbox ValidationTest against historical data, then tune for accuracy and traceability.
  4. 04GxP QualificationSupport IQ, OQ, and PQ documentation and align with QA review.
  5. 05Production RolloutDeploy in phases, with training, KPIs, and monitoring in place.

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Helix

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UDI

From Data to Decision in Minutes

Platform Capabilities

What the Platform Does

Six capabilities that work as one system, turning scattered documents and data into defensible, inspection-ready output. Select a capability to explore it.

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  • Analyse SOPs, protocols, reports, audit logs, and surveillance data together rather than in isolation, surfacing the relationships and discrepancies that hide when information is spread across systems.

    Less manual reconciliation, and a faster route to the insights that matter.

  • Turn structured and unstructured data into trend analysis, risk signals, and the supporting evidence your teams need to move from a question to a defensible answer.

    Faster, evidence-based decisions.

  • Draft SOPs, reports, and investigations with source attribution linked to every claim, so the audit trail is built in rather than added afterwards.

    Less time documenting, with stronger audit readiness.

  • Configure review, approval, and sign-off workflows to match the way your teams already operate.

    Faster workflows, without giving up oversight.

  • Every output carries its own reasoning, execution path, and source-linked evidence.

    The trust that drives adoption, and the readiness an inspection demands.

  • Identify gaps, inconsistencies, and compliance risks across your documents before they turn into findings.

    Better quality, and shorter review cycles.

Why Deploy AugmentX

Built for Regulated Life Sciences Environments

Expert knowledge first

Institutional knowledge, past decisions, and domain expertise brought together into one living intelligence layer your teams can draw on.

AI-augmented workflows

Your experts gain AI-driven analysis and automation while keeping control of the decisions that count.

Transparent and explainable

Every output traces back to its source data, reasoning, and execution history.

GxP-first architecture

Auditability, governance, and compliance built in from the ground up.

Rapid value delivery

Integrates with the systems you already run, with no major infrastructure change required.

Compliance-Ready

21 CFR Part 11GAMP 5GxPHIPAAGDPRSOC 2 in progress

Governance, auditability, and traceability designed to hold up under inspection.

FAQ

Frequently asked questions.

01What is AugmentX?

AugmentX is an AI platform that helps life sciences teams work through complex data, documents, and workflows more efficiently. The goal is not to replace expertise. It is to give experts a better starting point, reduce repetitive effort, and help them focus on the work that requires judgment.

02How does AugmentX fit into the way teams already work?

AugmentX is built to work alongside existing processes, not replace them. It helps bring together information from different systems so teams can spend less time pulling things together and more time using their expertise.

03How does AugmentX work with our existing systems?

AugmentX is designed to work with the information your teams already use. It can connect data, documents, and knowledge from across your environment, allowing users to access relevant information without having to search through multiple systems manually.

The approach can be tailored based on your existing technology landscape, security requirements, and intended use cases.

04How does AugmentX help experts stay in control?

AugmentX is designed to support expert judgment. The platform helps generate outputs and surface relevant information, but people remain responsible for review, validation, and final decisions. AI helps move the work forward. Experts provide the judgment.

05Can AugmentX be tailored to specific workflows?

Yes. AugmentX can be configured around specific business processes and areas of expertise.

Purpose-built AI agents can be designed to work with your organization's information, terminology, procedures, and workflow requirements. This allows the platform to support how your teams work rather than forcing them into a generic AI experience.

06How is AugmentX different from a general-purpose AI tool?

General-purpose AI tools are designed to answer a wide range of questions. AugmentX is built to support defined life sciences workflows using the information, context, and controls relevant to your organization.

It combines connected enterprise information, purpose-built AI agents, and expert review to support work that requires both efficiency and sound judgment.

07Is AugmentX built for regulated life sciences environments?

Yes. AugmentX is designed with the needs of regulated life sciences organizations in mind.

The platform supports controlled workflows, expert review, traceability, and evidence-based outputs. Its implementation can be aligned with the organization's intended use, risk profile, quality processes, and validation requirements.

08How does AugmentX support validation?

Validation should be based on how the platform is being used and the level of risk associated with that use.

AugmentX supports a risk-based approach that can be aligned with the intended workflow and your organization's quality requirements. The appropriate validation activities and documentation can be defined as part of implementation.

09How do teams typically get started with AugmentX?

Most teams start with one workflow or use case where the need is clear and the value is easy to show. From there, they can expand as they see results. A focused pilot can often be used to demonstrate value quickly. From there, the platform can be expanded based on business priorities and lessons learned during the initial implementation.

Next Steps

Turn Expertise Into Action

Put your expertise, processes, and data to work as trusted insights, faster decisions, and higher-quality outcomes, with AI-augmented workflows built for the way life sciences teams operate.