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Appraise, Action, Adapt & Adopt – Our continuous improvements in GCP
1 December 2021
By OracleBio

Earlier this year, we announced that OracleBio is now conducting quantitative image analysis on clinical trial samples in accordance with Good Clinical Practices (GCP).

Having recognised these standards, it is important to ensure that this high-level quality is maintained and that we continually review, evolve, and improve our dedicated GCP processes, activities, and systems. We do this by applying Continuous Improvement processes within our GCP workflow.

What is Continuous Improvement (CI)?

Continuous Improvement is an essential activity associated with quality processes in support of Good Clinical Practices. Within OracleBio, CI is championed by strong company culture, scientific knowledge, and ethics to conserve quality standards and improve overall business efficiencies.

CI, as defined by the International Organisation for Standards ISO15189, ratifies the importance of laboratories to improve the effectiveness of their quality management systems, by employing management reviews and ensuring that defined activities associated with corrective and preventative actions (CAPA) are in place to identify and eliminate issues to avert nonconformities.

What benefit does Continuous Improvement provide for OracleBio’s clients?

CI provides our clients with confidence in quantitative data integrity, so that data can then be included within their clinical trial package for regulatory submission.

OracleBio’s approach to Continuous Improvement

Our GCP team operates a proactive approach to continuously improve GCP activities and processes by utilising a monitoring, checking and reviewing cycle, whilst analysing key performance indicators to appraise GCP-related events and actions, identify potential issues and define strategies to further improve on quality. All CI activities are performed in line with OracleBio quality policies and procedures. Staff are trained following the implementation of any new or updated systems, procedures or documentation, implemented as part of improvement processes, to ensure that changes are accepted and adhered to in accordance with GCP.

OracleBio’s commitment to Continuous Improvement

In recent years, there has been considerable interest and investment worldwide in digital pathology. This includes the constantly changing field of computerised image analysis systems and procedures, resulting in the emergence of updated legislation and new support tools and algorithms. Considering this, OracleBio is committed to ensuring that we regularly appraise all quality processes, adapt to new regulatory digital/computer-based quality practices, and adopt new innovative technologies whilst actioning the removal of redundant or obsolete processes.

GCP Image Analysis Services Brochure

Download our GCP Services brochure by clicking the image below, or for more information on our GCP service offering, our continuous improvement processes, or to discuss your study requirements with us, click here to arrange to speak with our GCP experts.

 

The brochure includes:

  • An overview of GCP and its benefits (as above)
  • OracleBio’s GCP study workflow
  • OracleBio’s quality management framework

Find out more about OracleBio's Pathology Expertise

OracleBio's Quantitative Digital Pathology Services

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