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Quality & regulatory excellence

Our enterprise-grade Quality Management System is aligned with ICH GCP and built to support FDA 21 CFR Part 11 requirements, delivering regulatory confidence and operational excellence across global clinical programs.

Validated quality management

Redenlab works within a rigorously built and audited Quality Management System. Our trial-ready QMS ensures trial data is secure and adheres to data privacy regulations irrespective of jurisdiction. Our quality team have defined processes that meet the critical needs of digital health data.

  • Upload and manage all speech recordings from one place
  • Access to critical analysis in a secure environment
  • Maintain visibility of all transfer activities
  • Meet security and compliance requirements
Focused woman writing on a whiteboard during a business planning session.

Quality control and assurance processes

Robust SOP framework

Documented and audited procedures ensuring high standards of data quality, secure data handling, and data integrity throughout the study lifecycle phases.

Continuous and critical data reviewing and reporting mechanism.

Validated standardisation processes designed to minimise data loss.

Independent QC oversight

Expert-driven, continuous QC oversight ensuring rigorous monitoring of data quality across all study phases. 

Early identification of audio recording issues, enabling timely corrective actions and minimising data loss.

Regular feedback to site staff, helping improve recording practices and enhancing overall data quality.

Diligent data analysis

Our expert team of data scientists, medical officers and statisticians delivers advanced speech and language analysis to produce meaningful outcomes.

Objective analysis through a centralised and standardised processing pipeline, ensuring consistency across sites and languages.

Deep trial expertise

Experience driven knowledge of trial requirements.

Our validated in-house tools generate actionable insights into neurodevelopment disorders, improving trial outcomes and accelerating therapeutic development. 

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