Overcome challenges in clinical data workflows through clinical information management

Axtria’s core clinical information management capabilities encompass consulting & execution for clinical data platforms and implementation services.

Our clinical experts and SMEs advise on enterprise architectures & solution roadmap; industry trends and maximizing ROI; metadata repository and master data management; change management and migration strategy; GxP compliance; data governance; data lineage and traceability; CDISC, SDTM, ADaM; RWD & EHR, HL7, FHIR:

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

Clinical Solutions_ Innovating to transform clinical research, bolster trial success, and improve patient outcomes

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Enhance the value of trial insights with clinical data science

Leverage Axtria’s deep domain and consulting expertise in data science to maximize the value of insights generated from clinical trials; find and tell the hidden story in the data supporting product value proposition.

ML-based trial performance, recruiting, and likelihood of success

Machine Learning & Predictive AI to assess clinical protocols, site and patient fit for optimizing patient recruitment & trial performance.

AI enabled site & patient engagement

AI-driven insights to enhance site identification, patient recruitment and retention, overall trial efficiency for accelerated clinical success.

Gen AI applications with study data

Unlock the potential of Gen AI to automate clinical trial data curation, analysis, and reporting to drive efficiency and innovation in clinical study workflows.

ML framework and operations

Accelerate clinical trials with ML and MLOps, ensuring efficient model deployment, continuous monitoring, and scalable AI-driven insights for data-driven decision-making.

Patient matching to clinical trials

Enhance trial efficiency with AI-powered patient matching, identifying eligible participants faster while improving recruitment precision and trial outcomes.

ML-based clinical data monitoring

Ensure data integrity and compliance with AI/ML-driven monitoring, enabling real-time insights and proactive issue detection in clinical trials.

Axtria clinical innovation supports faster, better trials

Clinical trial optimization

Site selection

Axtria Rapid CSR

Axtria LUCCID

Clinical trial optimization

Expert designed and data informed clinical trial protocol
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

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Site selection

Identify relevant patient populations and where they are located
Link physician national provider identifier number to reach out to facilitate trial recruitment
Determine site feasibility based on operational performance, available patients, competing trials, and potential research fatigue

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30%–50% faster CSR authoring

Accelerate generation of first draft clinical study reports using GenAI
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

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Accelerate unstructured EHR to EDC data automation

Achieve data extraction time from 500 hours per patient to under 30 minutes – with over 90% accuracy through automated workflows.
Automate the movement of data from EHR to eCRF to EDC with GenAI
Minimize human errors in trial data entry and copying
Generate meaningful structured clinical insights from messy unstructured clinical notes
Leverage clinically trained large language models with dedicated clinical reasoning modules that steer and ground the system with biomedical knowledge

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Our work in late phase investigations supports a variety of study objectives and designs

Support for clinical research strategy and operations

Trial design and optimization
Promotional regulatory strategy
Site selection and support
Clinical analytics and data science
Data management and analysis
Promotional regulatory support
Clinical study report authoring

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.
Registry-like data capture system for longitudinal tracking

Phase IV randomized controlled trial

Support limited areas of the investigation 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)
Ownership of RWD/E or any additional pragmatic components

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 data/endpoints
Regulatory package preparation and submission support

Simplify clinical trials through solutions and innovations that maximize return on investment

Better designed trials for the right patients and endpoints

Reduce errors through good data management and science

Enhanced solutions Phase I-IV for continuity and ongoing support

Innovations transforming clinical research to improve patient care

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What are Axtria Clinical leaders thinking about?

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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Clinical Solutions

Transform clinical study report authoring process with GenAI powered automation

Clinical Solutions Reimagined - Delivering Value with GenAI

Accelerate clinical concept identification from unstructured data using GenAI

Harnessing GenAI for Smarter Clinical Trials: Faster, More Accurate Data Extraction

Transform clinical study report generation with GenAI

Transform clinical study report authoring process with GenAI powered automation

Clinical Solutions Reimagined - Delivering Value with GenAI

Watch on-demand webinar: Maximizing commercial performance by harnessing RWD and Clinical data

Overcome challenges in clinical data workflows through clinical information management