Life Sciences

Digital and agentic solutions for life sciences.

We partner with pharma, biotech, and medical device companies to modernize research, clinical development, manufacturing, and commercialization — now extended with governed, agentic AI that turns trusted data into faster, compliant decisions.

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Our expertise

Helping life sciences thrive in a digital-first world.

From accelerating drug discovery and improving patient recruitment to streamlining regulatory submissions, strengthening pharmacovigilance, and optimizing manufacturing — we combine GenAI, data engineering, DevSecOps, and quality engineering to reduce time-to-market, improve compliance, and bring therapies to patients faster.

Why Altimetrik

Accelerated innovation

Harness intelligent data platforms to bring life-saving therapies to market faster.

Custom solutions

We build strategies aligned with your unique business needs and goals.

Optimization strategies

Digital tools that improve production workflows for consistent quality and faster delivery.

Real-world data

Make data-powered decisions and optimize across your product lifecycle.

Five layers. Forty-five engineering disciplines.

ALTi AIOS is structured as five interlocking layers. Consume them selectively, or deploy end to end.

Clinical Development

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ALTi AIOS is structured as five interlocking layers. Consume them selectively, or deploy end to end.

Adaptive Clinical Trial Designs

Analyze interim results with ML to modify trials and identify effective drugs sooner.

Real-World Evidence (RWE) Integration

Enhance trial data with real-world insights on effectiveness and safety.

Patient-Centric Trials

Design around patient needs to improve recruitment and retention via digital platforms.

Master Protocols & Basket Trials

Evaluate multiple drugs in one trial using electronic data capture.

Companion Diagnostics

Use bioinformatics and genomics for targeted recruitment and personalized treatment.

Biomarker Identification & Validation

Validate biomarkers that predict treatment response for targeted therapies.

Remote & Decentralized Trials

Telemedicine and virtual monitoring to increase patient participation.

Data Standardization & Interoperability

Seamless data exchange with interoperable EHR and standardized health data.

Ethics, Risk & Compliance

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Stay ahead of regulatory change and keep processes tight — compliant, secure, and efficient end to end.

Regulatory Engagement & Expedited Review

Engage regulators early to speed feedback and approvals.

Continuous Compliance Monitoring

AI and analytics automatically track regulatory change.

Data Integrity & Transparency

Security measures ensure integrity across the product lifecycle.

Secure Document Management

Cloud-based storage for safe, accessible regulatory documents.

Risk Assessment & Mitigation

Automated assessments and mitigation tracking.

Global Regulatory Intelligence

Track and analyze global regulatory changes with digital tools.

Post-Marketing Surveillance

Monitor safety events, detect signals, and ensure reporting compliance.

Third-Party Auditing & Vendor Management

Streamline audits and monitor vendor compliance.

Commercial & Product Lifecycle

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Stay innovative, customer-focused, and data-driven as markets shift.

Post-Approval & Label Expansion

Monitor performance and plan expanded indications with real-world evidence.

Robust Clinical Evidence

Digital platforms for virtual trials and real-world evidence collection.

Targeted Marketing & Segmentation

Reach specific patient groups using data insights.

Pharmacovigilance

AI-powered monitoring of adverse events and safety concerns.

New Market Access

Demonstrate cost-effectiveness to payers with health economic data.

Patient Support Programs

Improve adherence and satisfaction via apps and portals.

CME Programs

Web-based education keeping HCPs current on the latest information.

KOL & Physician Engagement

Engage key opinion leaders through virtual platforms for advocacy.

Manufacturing, Quality & Supply Chain

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Streamline processes, ensure quality, and gain visibility across the supply chain.

Adaptive Production Design

Identify process gaps by correlating outcomes and events.

Supplier Resilience

Optimize CMO/CTL operations and streamline CoC/CoA processes.

Cold Chain Management

Sensors and real-time alerts for temperature-sensitive drugs.

Shop Floor to Top Floor Visibility

A single source of truth across sites and business units.

New Market Access

Automated packaging and smart labeling for compliance and safety.

Global Insight Centers

Centralized cloud data hubs for supply chain visibility and KPIs.

Last-Mile Quality

Quality intelligence platforms for real-time data sharing.

Risk Mitigation

Predictive analytics and scenario modeling to address risks proactively.

New · Agentic Solutions

Help for every team, from lab to launch.

Live today across R&D, commercial, quality, and manufacturing — with more on the way. Everything runs on one shared, trusted foundation.

R&D / Clinical

CSR Evidence Review

In build

Network Modeling

In build

Commercial / GTM

HCP Engagement Planning

MVP

Quality / Compliance

Deviation & CAPA Review

MVP

Manufacturing / Supply Chain

Batch Release Readiness

MVP

Foundation · cross-cutting

Life Sciences Context Layer

The shared, governed context every offering reasons over.

MVP

Reference deployments

Gemini Enterprise

OpenAI

Anthropic

Inside the platform

A team of AI agents for every part of your business.

Describe a goal in plain language, and a team of specialized agents plans, checks, and acts — with a person approving every step. 40+ agents across six focus areas, and growing.

Open the live demo

Live

12

agents

Commercial Operations

AI-powered next-best-action, omnichannel orchestration, and HCP engagement optimization.

Live

8

agents

Manufacturing & Quality

Batch release, CoA extraction, and OOS investigations within 21 CFR Part 11 guardrails.

Coming soon

10

agents

Medical Affairs

Medical-information requests, KOL engagement tracking, and publication planning.

Coming soon

9

agents

Clinical Operations

Site selection, protocol-deviation monitoring, and patient recruitment across trial portfolios.

Coming soon

7

agents

Supply Chain

Demand variability, supplier qualification, and inventory replenishment signals.

Coming soon

10

agents

IT Operations

Data engineering, migration, and governance for life sciences data in Lakehouse environments.

Manufacturing / Supply Chain

Batch Release Readiness

Release every batch with confidence.

The problem

CMO COAs and batch records arrive as static documents, forcing manual review, reconciliation, and release-package assembly.
In-spec results can still drift toward limits, but trend and OOT signals are often missed until later.
Release readiness is scattered across COA values, signatures, deviations, attachments, batch status, and supply context.

What you get

Converts validated enterprise documents into trusted, reusable intelligence that can drive downstream agentic workflows.
Identifies exceptions, emerging patterns, and risk signals early—before they disrupt operations, compliance, or customer outcomes.
Orchestrates governed decision-making across teams with human oversight, source-level traceability, and audit-ready evidence.

Built for trust & compliance

Quality Unit Review

Supports review-before-release workflows and release-package readiness.

Data Integrity

Field-level source highlights, reviewer actions, timestamps, and versioned outputs.

Quality Unit Review

Supports review-before-release workflows and release-package readiness.

GxP-ready Trace

Designed for audit trail, evidence linkage, and role-based release actions.

Quality / Compliance

Deviation & CAPA Review

Turn every deviation into a lesson that sticks.

The problem

Deviation closure does not always become deviation learning; repeat causes stay buried in QMS comments and attachments.
Aging investigations are hard to triage across site, product, equipment, CMO, batch, and related product context.
CAPA prioritization often lacks recurrence frequency, related batch exposure, and supply context.

What you get

Summarizes deviation narratives and TrackWise / QMS comments into evidence-linked RCA themes.
Identifies recurrence by site, equipment, product, batch, and process step.
Helps quality teams prioritize CAPA work on high-risk, repeatable causes while preserving human ownership of final conclusions.

Built for trust & compliance

Investigation Support

Connects failed parameter / discrepancy to related batches, products, and evidence.

RCA Traceability

Shows evidence path from deviation comments to suspected root-cause themes.

CAPA Governance

Keeps recommendations advisory with human-owned CAPA decisioning.

Audit Readiness

Preserves source references, assumptions, reviewer notes, and action history.

Commercial / GTM

HCP Engagement Planning

Reach the right physicians, the compliant way.

The problem

Commercial teams have fragmented signals across CRM, field notes, campaigns, consent, access, and HCP engagement.
It takes too long to translate market goals into compliant field actions.
Governance checks often happen after recommendations, creating rework and commercial compliance friction.

What you get

Translates product, market, and growth objectives into governed commercial action plans.
Prioritizes HCPs, accounts, and opportunities using explainable signals across potential, fit, engagement, and business value.
Applies consent, policy, frequency, channel, and compliance rules before recommended actions are activated.

Built for trust & compliance

Consent-aware

Consent, opt-out, frequency-cap, and channel eligibility rules applied before action creation.

Promotional Controls

Uses approved content and message themes rather than free-form promotional claims.

Human Review

Commercial users approve field actions before CRM execution.

Action Traceability

Captures recommendation rationale, rules applied, and outcome feedback.

R&D / Clinical

In build

CSR Evidence Review

Get to filing faster, with evidence you can trust.

The problem

CSR preparation pulls evidence from protocol, SAP, TLFs, datasets, safety narratives, templates, and review comments.
Review churn increases when numbers mismatch, source versions are stale, or claims are unsupported.
Medical writing, biostats, clinical, safety, and regulatory review handoffs are slow and document-heavy.

What you get

Creates a governed evidence-intelligence layer that connects clinical data, approved content, and regulatory deliverables.
Uses agentic authoring to accelerate document development with transparent sourcing and human oversight.
Continuously validates consistency, completeness, and version alignment to improve submission quality and shorten time to filing.

Built for trust & compliance

GCP-aligned Evidence

Source-backed drafting tied to protocol, S

QC Checks

Numeric, terminology, endpoint, population, and version consistency checks.

Review Routing

Medical writing, statistics, safety, clinical, and regulatory review states.

Submission Readiness

Outputs evidence map, QC report, source manifest, and open-issue log.

Data Governance

Life Sciences Context Layer

One source of truth every agent can reason over.

The problem

Agents cannot reason reliably if product, batch, deviation, HCP, study, and regulatory context remains fragmented.
Point solutions rebuild context repeatedly, slowing delivery and increasing governance risk.
Regulated workflows require source lineage, business meaning, human review, security controls, and explainable evidence paths.

What you get

Creates a conversational intelligence layer across the pharma enterprise, turning fragmented data and documents into trusted, decision-ready insights.
Connects signals across R&D, clinical, quality, manufacturing, supply chain, and commercial operations to reveal risks, opportunities, and dependencies.
Enables faster, more consistent decisions through governed recommendations, transparent evidence, and human-in-the-loop oversight.

Built for trust & compliance

Consent-aware

Defines entities, relationships, approved sources, and business terms.

Source Lineage

Maps agent answers back to documents, data products, and system-of-record context.

Access Control

Supports role-aware retrieval, tool access, and sensitive-data boundaries.

Operating Controls

Observability, evaluation, audit trace, and governance patterns across agents.

Our offerings

Discover the Altimetrik advantage.

A proven track record of speeding drug development, simplifying compliance and submissions, boosting provider engagement, and improving manufacturing and supply-chain visibility — backed by deep pharma domain expertise.

Unique Digital Business Methodology

A results-driven framework to deliver impactful outcomes quickly.

Value-First Partnership Models

Collaborating closely to align with your goals for measurable results.

Deep Digital Capabilities

Advanced tools and insights tailored to solve real business challenges.

Led by Domain Practitioners

Experienced practitioners guiding strategies that work in your field.

Case studies

From strategy to results.

Altimetrik built an integrated data hub for a global pharma leader, optimizing radioligand therapy supply chains — reducing costs and enhancing efficiency across the network.

Read the case study

Life Sciences · Oncology

Transforming cancer care with an integrated data hub for radioligand therapy.

FAQs

frequently asked questions

We build AI-enabled, 360° connected platforms with data analytics, integrate AI into legacy systems, and apply advanced algorithms — contributing to more than 16-fold improvement in the drug discovery process.

Through cloud, AI/ML, blockchain, Salesforce customization, and data analytics across device manufacturing and drug discovery, we help organizations achieve operational excellence and become data-driven.

A portfolio of governed, agentic offerings — batch release, deviation & CAPA, HCP engagement, CSR evidence review, and a shared context layer — that pair agentic speed with human oversight and audit-ready evidence.

Leave your contact details via our contact page and our team will reach out to discuss your goals.

Regulatory posture

MVPs are decision-support and workflow-acceleration patterns. Customer-specific validation, Part 11 / e-signature controls, and production GxP qualification remain implementation workstreams.

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