Validated quality management
Redenlab operates within a rigorously designed and independently audited Quality Management System that provides robust processes to support the critical requirements of digital health and speech data in regulated clinical research environments.
Our practices align with globally recognised regulatory and data protection frameworks, including ICH E6(R2) Good Clinical Practice, FDA 21 CFR Part 11 requirements for electronic records and signatures, HIPAA data protection standards, and the GDPR.
Key offerings:
- Centralised data management for all speech recordings through a single secure, regulated platform.
- Advanced speech analytics delivered within a secure and controlled analytical environment.
- Full data transparency and traceability for sponsors across all data‑transfer and processing activities.
- Stringent security, privacy, and compliance controls tailored for clinical‑trial environments.
Quality control and assurance capabilities
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.
