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Providing regulatory support to clinical research laboratories

The laws and regulations that govern research on humans, or the samples and data collected from humans, are complex. Those performing or overseeing clinical research studies need to understand and implement the requirements and best practices to avoid regulatory risk.

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ResLabQ&C offers consultancy services to assist and ensure compliance with the quality standards expected by the regulators in laboratory facilities conducting clinical research.

 

Whether your facility is within a university, hospital, research institute, or commercial organisation, we can provide flexible services and tailored approaches to assist you in the development and implementation of quality strategies that support compliance and minimise regulatory risk.

Services

Our services are currently primarily focused on 3 regulatory environments:​​​​

Facilities that process and analyse samples collected from clinical trial participants where the MHRA requires all operations to be compliant with laboratory Good Clinical Practice (GCP) standards (also known as Good Clinical Laboratory Practice; GCLP).

HTA-licensed facilities that procure, process, test, store, distribute, import, or export tissue and cells for human application (application sector). 

HTA-licensed facilities and biobanks that store cells and tissues for future research (research sector).

We can help on a study-specific basis, and also support laboratories and facilities delivering multiple projects and activities.

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