Practical AI Solutions for quality & efficiency from Clinical Development to Post Marketing

Turning AI into practical value across the life sciences lifecycle

Artificial intelligence is moving quickly from experimentation to application across the life sciences industry.

For pharmaceutical and biotech companies, the opportunity is identify where AI can solve a real business or scientific problem, improve the quality or speed of an existing process and create measurable value, without compromising human expertise, compliance or accountability.

Navitas Life Sciences applies AI, machine learning and advanced analytics across multiple areas of the life sciences value chain.

From supporting clinical trial data and biostatistics to improving pharmacovigilance workflows, regulatory intelligence, artwork and labelling, CMC change management, medical strategy and customer interactions, our AI initiatives are focused on practical applications.

AI at Navitas is about augmenting expertise.

AI Solutions for Pharma and Biotech

Here is what Navitas is doing with AI across the business.
Across Navitas, our teams are exploring and deploying AI in areas including:

Clinical Development: AI-enabled trial analytics | Intelligent oversight | AI-supported CDM | RWD & RWE | DCTs & hybrid trials.
Data Sciences: AI-augmented biostatistics | Clinical data analytics | AI-assisted data review | Data integration | Statistical programming | Visualization.
Pharmacovigilance & Safety: Signal reporting | Safety intelligence | MICC sentiment analysis | AI-enabled PV.
Regulatory: Regulatory intelligence | Artwork & labelling | CMC change management .
Medical & Advisory: AI strategy | Medical AI advisory | AI transformation.

Our AI-Enabled Clinical Development Capabilities

AI can support clinical development by helping study teams access timely insights, identify areas requiring attention and make more informed decisions across the trial lifecycle.

Our approach combines AI, advanced analytics and clinical expertise to complement the operational and scientific judgment required to successfully execute clinical programs.

AI-Enabled Clinical Trial Analytics: Our Oneclinical Analytics provides near real-time data insights to support study teams with greater visibility into clinical trial performance and emerging areas of attention.
Intelligent Clinical Trial Oversight: Use data driven insights to support proactive study oversight, identify potential risks and strengthen decision-making throughout study execution.
AI-Supported Clinical Data Management: Apply intelligent approaches to data review, validation and quality management to reduce manual effort and improve visibility across clinical data workflows.
Real-World Data & Evidence: Apply AI and advanced analytics to EHR/EMR data, registries and other real-world data sources to generate insights that complement clinical trial evidence.
Technology-Enabled Decentralized & Hybrid Trials: Integrate remote data collection like Readout AI, patient engagement and multiple technology platforms to support cohesive, data-driven trial workflows.

AI & Data Sciences for Clinical Research

The growing volume, complexity and diversity of clinical data creates new opportunities for AI and advanced analytics to support biostatistics, clinical data management and statistical programming.

Navitas Life Sciences combines AI/ML capabilities with data science and therapeutic expertise to transform complex clinical data into actionable intelligence.

AI-Augmented Biostatistics: Combine machine learning and advanced analytics with biostatistical expertise to support predictive analysis, study design, treatment-response analysis and data-driven decision-making while maintaining statistical rigor.
Clinical Data Analytics & Integration: Connect and harmonize data from disparate clinical, healthcare and research systems to create a stronger foundation for analysis and AI-enabled insights.
AI-Assisted Data Review & Quality Checks: Use intelligent approaches to identify patterns, anomalies and areas requiring further review, helping data teams improve efficiency and focus expert attention where it matters most.
Advanced Data Visualization: Use SAS, R and Power BI, integrated with clinical data sources such as EDC, to transform complex datasets into clear, decision-ready insights.
Statistical Programming & Analytics: Explore AI-assisted approaches to streamline repetitive analytical workflows while maintaining expert review, validation and traceability.

AI Enabled Regulatory Affairs

Regulatory teams manage a constantly changing landscape of regulatory requirements, product information and post-approval lifecycle activities. AI can help simplify these workflows, accelerate information processing and support regulatory professionals in focusing on higher-value decisions and staying compliant.

AI Enabled Safety & Pharmacovigilance

Apply AI, automation and advanced analytics across pharmacovigilance processes to support literature surveillance, case intake, safety data processing, quality review, Regulatory & Drug intelligence, Aggregate reports and MICC detection activities. AI-enabled capabilities can assist with data extraction, classification, coding support, narrative generation, compliance monitoring and safety trend analysis, helping organizations improve operational efficiency while maintaining regulatory oversight.

AI Strategy & Advisory for Life Sciences

AI adoption is not only a technology challenge. For life sciences organizations, it requires a clear understanding of where AI can create value, how it should be implemented and what capabilities and governance are needed to support responsible adoption.

Our Advisory & Consulting teams help organizations translate AI opportunities into practical strategies aligned with their business and functional priorities.

AI Strategy Development: Support life sciences organizations in identifying AI opportunities, defining strategic priorities and developing an approach for implementation.
Medical AI Strategy: Our Advisory team is developing an AI strategy for the Medical function of a top-three pharmaceutical company, helping translate emerging AI opportunities into a practical functional strategy.
AI Transformation Advisory: Help organizations assess where AI can augment existing processes, capabilities and operating models..
AI Governance & Adoption: Support organizations in considering the capabilities, governance and operating principles required to scale AI responsibly..

aiREADY Platform

NAVITAS has developed the aiREADY Platform to enable AI capabilities across key business functions, including Clinical, Regulatory and PV/Safety.
Initially developed with targeted AI capabilities, the platform is continually expanding across business functions to support the evolving needs of life sciences operations. It is designed to help drive faster operational throughput, greater accuracy and scalable AI models that can adapt to growing business requirements and increasing data volumes.
aiREADY is designed to work with Enterprise level systems by leveraging existing investments, without compromising on data governance.

AI/ML across the life sciences value chain powered by aiREADY Platform

Clinical Development: AI-enabled clinical trial analytics, intelligent trial oversight, AI-supported clinical data management, real-world data & evidence, technology-enabled decentralized and hybrid trials
Data Sciences: AI-augmented biostatistics, clinical data analytics and integration, AI-assisted data review and quality checks, advanced data visualization, statistical programming and analytics
Pharmacovigilance & Safety: AI-assisted literature surveillance, AI-supported case processing and quality review, PV knowledge intelligence, AI-supported aggregate reports, signal and safety intelligence, Regulatory & Drug intelligence, MICC sentiment analysis
Regulatory Affairs: Regulatory intelligence, AI for artwork & labelling including Ninestars, CMC change management, regulatory publishing including AIready, post-approval and regulatory lifecycle management
Medical & Advisory: AI strategy development, medical AI strategy, AI transformation advisory, AI governance and adoption
Artwork & Labelling / Labelnet: AI perspectives for Artwork & Labelling and emerging AI applications through Labelnet

Brochure

Efficient Clinical Trials: Real-Time Oversight & Insights

Navitas Life Sciences has In-depth domain expertise, vast experience in managing global studies, incorporated proven technologies, and more to manage efficient trials.

AI Tool

OneClinical® Analytics Offers AI-Powered Efficiency

Learn more about how our OneClinical® platform leverages artificial intelligence (AI) and machine learning to revolutionize AI in clinical trials, providing near real-time data and analytics to enhance trial efficiency and outcomes.