The Siesta Group

Quality Control

With over two decades of groundbreaking innovation pioneering the field of computer- assisted sleep scoring, The Siesta Group is setting the benchmark in measuring, analyzing, and interpreting bio-signals related to the workings of the brain during sleep and wakefulness, as well as physical activity.

Proactive Risk Mitigation

20 years of clinical trials experience informs us about all the mistakes that can happen, and how to apply proactive risk mitigation. Our QC-checks cover all stages of a clinical trial.

During Setup

• site training (adapted to staff experience and study protocol)
• review & certification of test recordings

During Study

• 100 % rule (algorithmic, visual and consistency checks of all recordings)
• real-time quality feed-back to stop perpetuation of errors immediately

During Reconciliation

• plausibility and data integrity checks of all recordings

Safeguarding Data Integrity

Our proprietary and published comparative spectral analysis of individual recordings “EEG fingerprinting” (Lewandowski et al., 2013) is an essential part of our quality monitoring to safeguard data integrity.

Real-time Quality Control

To prevent error propagation as fast as possible, our in-study quality control mechanisms combine immediate detection of data acquisition issues with specific re-training schemes. Especially for experimental protocols such as the maintenance-of-wakefulness-test (MWT), where precisely following the protocol is a crucial part of data acquisition itself, highest biomarker extraction stability requires continuous quality monitoring.

Retrospective Quality Control

Post-hoc analysis of data from a phase 1 study performed NOT under supervision of TSG revealed significant data loss due to improper vigilance control during recording while subjects should have performed a cognitive task. In cases such as this one we find up to one quarter of the trials un-scorable.

Due to vigilance decrements 20% of response were not scoreable.