Good Clinical Practice (GCP) is an internationally recognised ethical and scientific standard for designing, recording and reporting trials that involve the participation of human subjects.
Studies conducted in accordance with this standard provides assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible (EMA Website).
For quantitative image analysis data to be included in a data package submitted to regulatory authorities, it is essential that it is generated using a workflow that is in accordance with GCP principles.
OracleBio can generate quantitative image analysis data to GCP standards, allowing you to extract maximum value from your clinical trials. Engaging with you from an early stage, we work with you to devise and execute an image analysis strategy for your specific regulatory package.
Providing Confidence in Clinical Data
Experienced GCP Team
All OracleBio staff have undergone comprehensive GCP training.
OracleBio’s GCP Team is built on extensive experience, with 50+ years of regulatory experience combined. Working to GxP standards and previously having implemented GxP Image Analysis systems, they have supported numerous projects in a regulatory environment.
Clinical Pathologists
OracleBio’s practicing consultant clinical pathologists work closely with our image analysis scientists to support tissue annotations, algorithm development and validation.
Furthermore, our workflow and software allow us to work collegiately with client pathologists to support clinical study projects.
Quality Control
Throughout the image analysis workflow each stage of sample management, data generation and handling involves periodic process checks to ensure data integrity.
Processes are documented according to the OracleBio Clinical Study Plan, SOPs and required GCP regulations.
Image Analysis Expertise
OracleBio are image analysis experts – we have a team of scientists who are highly skilled in quantitative digital pathology.
As a result we are able to address complex and challenging image analysis studies.
Quality Assurance & Quality Management Framework
OracleBio’s Quality Assurance Manager is responsible for leading and maintaining an effective Quality Management Framework independently of the GCP team.
Our internal QA capabilities ensure we are working to all relevant quality, ethical and legal standards applicable to clinical trials. We are happy to facilitate client audits and support regulatory inspections.
Validated Software in a Secure IT Infrastructure
OracleBio has validated the Visiopharm software platform as part of the GCP image analysis workflow.
The validated software runs on validated virtual machines on the OracleBio secure server stored in a local tier III data centre (DataVita).
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
Quantitative Image Analysis and GCP: Q&A Blog
Looking to speak with our GCP experts about your study?
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