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Clinical

Leveraging Agentic AI and advanced
analytics to power smarter trials.

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Consulting, expert talent & clinical technology mastery

Bringing a complex trial from concept to close demands more than point solutions. Axtria supports clinical R&D with tailored strategic insights, on-demand expert teams, seamless clinical data orchestration, and best-in-class digital platforms to keep timelines tight, budgets under control, and compliance on-point.

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Enable connected and compliant clinical systems

Leverage our end-to-end clinical data and information management solutions, from strategic consulting to hands-on execution. We guide life science organizations through the entire clinical technology lifecycle including designing and implementing clinical data platforms, and defining solution roadmaps by aligning with evolving industry standards to maximize ROI.

Ensure your clinical systems are interoperable, compliant, and insight-ready across metadata and master data management through CDISC, SDTM, and real-world data standards such as HL7 and FHIR. Build robust enterprise architecture, clinical data governance and management systems, and GxP compliance ecosystems supported by our deep domain expertise.

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Integrated strategy, talent,
data & technology -
engineered around your
clinical research program

R&D platform enablement

Specialty staff augmentation

Data management & quality

Clinical strategy, innovation & adoption

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  • Clinical GenAI & agentic-workflow accelerators
  • End-to-end platform design, build & global rollout
  • System integrations (eTMF, CTMS, ePRO, LIMS)
  • Change-management, training & user-adoption services

Let's talk
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  • Biostatisticians & programming
  • Clinical data managers & CDISC specialists
  • Project managers and vendor-oversight leads
  • RWD and data analysts
  • Medical writers

Let's talk
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  • Clinical data strategy design & implementation
  • Clinical data management, warehousing, & system integration
  • Governance, clinical standards & terminologies, quality
  • Study insights & operational reporting, dashboarding

Let's talk
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  • Trial design (Phase I–III) with adaptive/Bayesian options
  • Indication prioritization and portfolio gap analysis
  • Feasibility & site-selection (patient prevalence, site performance, timelines)
  • Opportunity sizing and budget modeling

Let's talk

R&D platform enablement

img_section2_elevate outcomes_a

  • Clinical GenAI & agentic-workflow accelerators
  • End-to-end platform design, build & global rollout
  • System integrations (eTMF, CTMS, ePRO, LIMS)
  • Change-management, training & user-adoption services

Let's talk

Specialty staff augmentation

Data management & quality

Clinical strategy, innovation & adoption

What do you want to
achieve?

  • Optimize clinical trials
    • Optimize clinical trials

    Clinical trial optimization

    • Expert-designed and data-informed clinical trial protocol development
    • Testing trial inclusion/exclusion criteria against real-world data
    • Analysis/re-analysis of de-identified electronic health record data
    • Integration of social determinants of health data for trial diversity, equity, and inclusion
    Let's talk
  • Improve site selection
    • Improve site selection

    Site selection

    • Identify relevant patient populations and where they are located
    • Link physician national provider identifier number to facilitate trial recruitment
    • Determine site feasibility based on operational performance, available patients, competing trials, and potential research fatigue
    Let's talk
  • Enable faster CSR authoring
    • Enable faster CSR

    Axtria rapid CSR

    • Achieve 30%–50% faster CSR authoring
    • Accelerate the generation of first draft clinical study reports using Generative AI
    • Input tables, listings, and figures, and output narrative summaries of high-level results
    • Prompt engineer with iterative feedback from experts for scientific tone and preparation for regulatory submission
    • Substantially reduce NDA approval timelines
    Let's talk
  • Accelerate EHR to EDC data automation
    • Accelerate EMR to EDC data automation

    Axtria LUCCID

    • Accelerate the extraction and transformation of unstructured EHR data into structured analysis-ready formats for seamless integration with downstream clinical systems
    • Achieve data extraction time from 500 hours per patient to under 30 minutes, with over 90% accuracy through automated workflows
    • Minimize human errors in trial data entry and copying
    • Generate meaningful, structured clinical insights from unstructured clinical notes
    Let's talk
  • Support clinical research strategy & operations
    • support clinical research stratgey

    Strategy & operations

    • Trial design and optimization
    • Promotional regulatory strategy and support
    • Site selection and support
    • Clinical analytics and data science
    • Data management and analysis
    • Clinical study report authoring
    Let’s talk
  • Streamline post-launch prospective data collection
    • Streamlining post launch prospective

    Post-launch prospective data collection

    • Multi-pronged approach with multiple data partners for comprehensive identification and collection of fit-for-purpose prospective data
    • Integration across data types, including consented trial data, linked tokenization to administrative claims, wearable devices, digital data, social determinants of health, etc.
    • A registry-like data capture system for longitudinal tracking able to be linked to retrospective or prospective claims
    Let’s talk
  • Accelerate phase IV randomized controlled trial
    • Accelerae phase IV

    Randomized controlled trial

    • Support investigations consistent with our business and areas of expertise
    • Manage the overall Phase IV program as coordinating PMO
    • Vendor selection and management (CRO, labs, IRT, data management)
    • RWD collection and RWE generation
    • Support for pragmatic trial design and implementation
    Let’s talk
  • Drive pragmatic trial investigations
    • Drive pragmatic trials

    Pragmatic trial investigations

    • Support the full scope of the investigation
    • Trial design, feasibility
    • Statistical analysis plan
    • Site contracting (through robust site network partnerships)
    • Trial initiation, conduct, and closure
    • Data Pipeline, primary data collection
    • Operational dashboarding
    • Integration of RWD and RWD endpoints
    • Regulatory package preparation and submission support
    Let’s talk
Optimize clinical trials

Clinical trial optimization

  • Expert-designed and data-informed clinical trial protocol development
  • Testing trial inclusion/exclusion criteria against real-world data
  • Analysis/re-analysis of de-identified electronic health record data
  • Integration of social determinants of health data for trial diversity, equity, and inclusion
Let's talk
Improve site selection

Site selection

  • Identify relevant patient populations and where they are located
  • Link physician national provider identifier number to facilitate trial recruitment
  • Determine site feasibility based on operational performance, available patients, competing trials, and potential research fatigue
Let's talk
Enable faster CSR

Axtria rapid CSR

  • Achieve 30%–50% faster CSR authoring
  • Accelerate the generation of first draft clinical study reports using Generative AI
  • Input tables, listings, and figures, and output narrative summaries of high-level results
  • Prompt engineer with iterative feedback from experts for scientific tone and preparation for regulatory submission
  • Substantially reduce NDA approval timelines
Let's talk
Accelerate EMR to EDC data automation

Axtria LUCCID

  • Accelerate the extraction and transformation of unstructured EHR data into structured analysis-ready formats for seamless integration with downstream clinical systems
  • Achieve data extraction time from 500 hours per patient to under 30 minutes, with over 90% accuracy through automated workflows
  • Minimize human errors in trial data entry and copying
  • Generate meaningful, structured clinical insights from unstructured clinical notes
Let's talk
support clinical research stratgey

Strategy & operations

  • Trial design and optimization
  • Promotional regulatory strategy and support
  • Site selection and support
  • Clinical analytics and data science
  • Data management and analysis
  • Clinical study report authoring
Let’s talk
Streamlining post launch prospective

Post-launch prospective data collection

  • Multi-pronged approach with multiple data partners for comprehensive identification and collection of fit-for-purpose prospective data
  • Integration across data types, including consented trial data, linked tokenization to administrative claims, wearable devices, digital data, social determinants of health, etc.
  • A registry-like data capture system for longitudinal tracking able to be linked to retrospective or prospective claims
Let’s talk
Accelerae phase IV

Randomized controlled trial

  • Support investigations consistent with our business and areas of expertise
  • Manage the overall Phase IV program as coordinating PMO
  • Vendor selection and management (CRO, labs, IRT, data management)
  • RWD collection and RWE generation
  • Support for pragmatic trial design and implementation
Let’s talk
Drive pragmatic trials

Pragmatic trial investigations

  • Support the full scope of the investigation
  • Trial design, feasibility
  • Statistical analysis plan
  • Site contracting (through robust site network partnerships)
  • Trial initiation, conduct, and closure
  • Data Pipeline, primary data collection
  • Operational dashboarding
  • Integration of RWD and RWD endpoints
  • Regulatory package preparation and submission support
Let’s talk

Why choose
Axtria?

Unparalleled expertise in clinical operations and technology

Decades of experience improving clinical trials for sponsors, sites, and patients, across academia, pharma, CROs, and next-gen AI-powered tech.

Next-gen technology innovation at scale

Our team can evaluate your current systems, pinpoint critical gaps, and streamline the end‑to‑end licensing, implementation, and scaling of clinical technologies to accelerate and optimize your trials.

Agentic and GenAI applications with study data

Platform-agnostic AI solutions to streamline workflows, automate data tasks, and enhance decisions, whether building new tools or integrating the best.

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Methodologically rigorous analytics

Our experts apply robust, scientifically sound analytical methodologies to deliver precise, reliable insights that drive evidence‑based decisions in clinical research.

Strategize better with our insights

White Paper
Harnessing GenAI for Smarter Clinical Trials: Faster, More Accurate Data Extraction
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White Paper
GenAI-Enabled Automation to Eliminate Clinical Trial Data Bottlenecks and Errors
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White Paper
30%–50% Faster Clinical Study Reports with Generative Artificial Intelligence-Powered Automation
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