Ensuring data validity and protocol compliance

Monitoring in clinical trials is a quality control measure to ensure patient safety, data integrity, and to make sure patient’s rights are respected. Palleos employs risk monitoring strategies based on our overall quality risk management approach to make sure to focus on the right aspects, at the right time, while also offering other approaches.

Monitoring Archiv

We apply different strategies to conduct monitoring: In addition to the regular visits of sites („on-site monitoring“), our team ensures the supervision of the sites by telephone monitoring (so-called „remote monitoring“). Furthermore, we make us of the method of „centralized monitoring“. This is a monitoring system in which the data can be checked for inconsistencies over several sites. As monitoring activities are one of the major cost drivers of clinical trials, in recent years, a new approach has been developed with the „Risk Monitoring“ which aims to use the resources for the monitoring more efficiently: Instead of carrying out 100% SDV, the monitoring focuses on those data, which are critical for the clinical trial – „laser instead of floodlight“.

 

The intensity of the monitoring activities is subject to a preliminary risk analysis, a systematic and technically complex method for the determination of risky areas within a clinical study. We specifically target our limited monitoring capacity at such areas. This risk-oriented quality management approach is also supported by regulators.

Our Monitoring services include

Pre-study visits

Setup

Initiation visits

Setup

Regular monitoring visits

Execution

On-site, online and central monitoring

Execution

Co-monitoring

Setup

Execution

Closure

Query management

Execution

Closure

Close-out visits

Closure

Risk monitoring

Development

Setup

Execution

Closure

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