Data Science & Analytics

Enhance the power of your trials

Quality clinical data is vital in any clinical study. Aixial has the expertise, systems, processes and resources to ensure we deliver your results to the highest quality. Our approach is to design each trial database and dataflow with flexibility to achieve the end result while adapting to any unforeseen changes in the trial lifecycle.

Aixial delivers precise data for complex trials

Aixial Data and Analytics services will help you to make fast, accurate deliveries despite the increasing volumes, types, and sources of data of today’s clinical trials. Our goal is to support you by understanding and using all data most effectively.

Aixial Services:

• Data Management, Statistical Programming, Biostatistics and Project Management
• Large scale Functional Service Provision (FSP)
• Statistical Consultancy
• ISS/ISEs
• Systems development and integration

Our Experience and Resources

Clinical Data Management

Aixial provides end to end services that facilitate the efficient collection and management of clinical data. Through our clinical data science expertise and a focus on solutions, we combine the latest technologies, robust processes, and a flexible approach to ensure data quality and integrity.

Aixial’s Services:

• Database design for eCRF and eSource
• Validation and maintenance of your database to meet protocol needs
• Creation, maintenance, and governance of sponsor-specific eCRF libraries
• Data validation specifications, programming, and testing
• Data loading and/or integration with IRT and other external systems for efficiency and
  data consistency
• Comprehensive data management planning and documentation
• Medical coding using standard dictionaries including MedDRA and WHODRUG
• Reconciliation of SAE and external data
• Clinical data quality review for inconsistencies, trends, and outliers
• Production and review of live clinical trial metrics

Key Experience

• 12+ Years average experience of Lead Data Managers
• Experience across Phases I – IV extending to registries and observational studies
• <95% databases have external third-party data integrated with clinical data
• Long term studies (up to 12 years) with annual interim analyses
• Experience of a range of EDC systems including encapsia, Medidata Rave, and Oracle InForm

Aixial manages critical deliveries within tight timelines:

Biostatistics

Our Biostatistics Team adds value to your project with strong expertise in clinical study design and data analysis. We provide high quality CDISC compliant datasets together with insightful statistical analysis.

Core Services:

• Statistical input to trial design and protocols, including sample size calculations
  Randomization strategies and treatment allocation lists
• CDISC compliant SDTM domains, ADaM datasets and additional eCRT package supporting documents
• Statistical analysis plans
• Programming and production of interim and final tables, figures, and listings
• Statistical consultancy, including publication/abstract support, ISS and ISE delivery
• SMCs and the provision of independent statisticians for IDMCs

Key Experience:

• Biostatisticians have on average < 15 years industry experience
• Senior statistical programmers have on average < 10 years industry experience
• Experience across Phases I – IV and all therapeutic areas
• Experienced in complex and adaptive study designs
• Experienced in programming with SAS and R
• CDISC conversion experience

Aixial manages critical deliveries within tight timelines:

Ensuring Regulatory Compliance With CDISC

Adhering to industry standards

Proven scalability and management of large data volumes

Aixial routinely works with both large data or programs of studies

Large Data Volumes:

• Single large studies with thousands of patients
• Registries
• Observational studies
• Real World Data
• Prospective and retrospective collection of data

Key Success Factors:

• Flexible team structures adapt to study design changes and sponsor needs
• Powerful modern system architecture designed for speed and scalability
• Rapid incorporation of multiple data sources (e.g., ePRO, Laboratory Data, IRT)
• Key progress updates and summarization of study metrics for easy oversight
• Real time visibility of clinical data and status
• System adaptability (e.g., study vs country vs site access management)

Functional Service Provision

We have extensive experience in governance, management, and partnership as a Functional Service Provider for both pharma and biotech companies. Our approach is tailored to your requirements and adapted as the partnership evolves.

Key Success Factors:

• Flexible team structures
• Governance model with clear leadership, goals, and implementation strategis
• Customized partnership approach
• Proven project control with key progress updates for easy oversight

Systems and Technologies

Our teams have developed, customized, and integrated multiple technologies for
fast, quality deliveries for 22 years. All our solutions are fully validated and have
been successfully audited multiple times.

System Experience:

• Our own holistic clinical data platform
• Medidata Rave
• Oracle Inform
• SAS
• IBM Cognos BI
• Microsoft Power BI
• TIBCO SpotFire

Aixial Data and Analytics services offer

• Experience and expertise across therapeutic areas and study phases
• Professional, dependable, and cost effective customer service that builds long term relationships
• Rapid deliveries with a focus on data quality and integrity
• Powerful and innovative technology to make the best of your data
• Loyal, stable team with high staff retention

Get in touch with us today to discuss your upcoming clinical trial needs and how our experts can help. We anticipate. We adapt. We embrace every challenge. We are where you want to be.

Reach out to us at info@aixial.com