Axio Research Corporation
Contract research organization providing statistical, analytical, software and consulting services across the drug development lifecycle. Core activities include adaptive and model-informed clinical trial design and simulation, biometrics and clinical data management, real-world evidence analytics and external control construction, regulatory submission support for datasets and analysis programs, health economics and outcomes research, AI/ML governance for regulated workflows, software platforms for trial design and trial implementation, and Chemistry, Manufacturing & Controls (CMC) strategy and scale-up guidance.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Trial design and simulation platform
Platform for trial design, adaptive simulations and protocol optimization using Bayesian and advanced statistical methods.
Exact statistical inference and specialized analysis software
Software suite providing exact statistical methods and specialized inference tools for trial design and analysis.
Trial implementation and study operations software
Software to support trial implementation tasks including randomization, site and patient management workflows and operational decision support.
Systematic literature review and living evidence platform
Platform for conducting and managing systematic literature reviews with AI-enabled screening, extraction and continuous evidence updates to support HEOR and HTA workflows.
Trial design and simulation platform
Platform for trial design, adaptive simulations and protocol optimization using Bayesian and advanced statistical methods.
Exact statistical inference and specialized analysis software
Software suite providing exact statistical methods and specialized inference tools for trial design and analysis.
Trial implementation and study operations software
Software to support trial implementation tasks including randomization, site and patient management workflows and operational decision support.
Systematic literature review and living evidence platform
Platform for conducting and managing systematic literature reviews with AI-enabled screening, extraction and continuous evidence updates to support HEOR and HTA workflows.
Services
Consulting for adaptive and model-informed clinical trial designs, including platform trial setups, simulation and protocol optimisation.
Statistical planning, randomization, analysis and monitoring services across trial phases.
Data capture, cleaning, standards mapping and support for preparation of regulatory submission packages and Study Data Standardization Plans.
Preparation of analysis programs, automation, program documentation and packaging of code for regulatory review following agency guidance and CDISC standards.
RWD acquisition, curation and analysis to construct external or synthetic control cohorts and support RWE strategies.
Regulatory planning, safety and submission support, engagement preparation and alignment with HTA and payer requirements.
Consulting for adaptive and model-informed clinical trial designs, including platform trial setups, simulation and protocol optimisation.
Statistical planning, randomization, analysis and monitoring services across trial phases.
Data capture, cleaning, standards mapping and support for preparation of regulatory submission packages and Study Data Standardization Plans.
Preparation of analysis programs, automation, program documentation and packaging of code for regulatory review following agency guidance and CDISC standards.
RWD acquisition, curation and analysis to construct external or synthetic control cohorts and support RWE strategies.
Regulatory planning, safety and submission support, engagement preparation and alignment with HTA and payer requirements.
Expertise Areas
- Adaptive clinical trial design and platform trials
- Clinical biostatistics and end-to-end biometrics
- Clinical data management and regulatory dataset production (SDTM/ADaM)
- Trial simulation and Bayesian decision-support
Key Technologies
- Bayesian adaptive trial simulation
- Model-informed drug development (MIDD) and PK/PD modelling
- CDISC standards (SDTM, ADaM, define-XML) and SDSP workflows
- Electronic submission packaging conventions for analysis programs
News & Updates
Conference participation and presentations on market access and HEOR topics.
Webinar covering statistical monitoring approaches to improve trial oversight.
Summary and commentary on FDA technical specification documents and therapeutic-area-specific CDISC implementation considerations, including examples and recommendations for Study Data Standardization Plans.
Guidance on which analysis and programming files to include in regulatory submissions, acceptable formats and file naming conventions, agency-specific expectations and recommended documentation.
Perspective on using synthetic data, external control arms and decentralized extensions to accelerate access and strengthen evidence generation.
Announcement of a partnership to combine an AI-enabled systematic literature review platform with automated screening and extraction to support HEOR and HTA workflows.
Conference participation and presentations on market access and HEOR topics.
Webinar covering statistical monitoring approaches to improve trial oversight.
Summary and commentary on FDA technical specification documents and therapeutic-area-specific CDISC implementation considerations, including examples and recommendations for Study Data Standardization Plans.
Guidance on which analysis and programming files to include in regulatory submissions, acceptable formats and file naming conventions, agency-specific expectations and recommended documentation.
Perspective on using synthetic data, external control arms and decentralized extensions to accelerate access and strengthen evidence generation.
Announcement of a partnership to combine an AI-enabled systematic literature review platform with automated screening and extraction to support HEOR and HTA workflows.