GCP Image Analysis Services
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 and regulatory guidance. OracleBio can generate quantitative image analysis data to a regulatory standard, allowing you to extract maximum value from your clinical trials. Engaging with you from an early stage, we work with you to devise and support an image analysis strategy to deliver high quality data to a regulatory standard.
All OracleBio staff have undergone comprehensive GCP training.
OracleBio’s GCP Team is built on extensive regulatory experience, having worked to GxP standards (GCP & GLP) implementing GCP Image Analysis systems and supporting numerous projects within regulated environments.
OracleBio’s 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.
Processes are documented according to the OracleBio clinical study plan, SOPs and required GCP regulations.
As a result, we perform complex and challenging image analysis studies to the highest quality standards.
OracleBio’s Senior Quality Assurance (QA) 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.
The validated software runs within a validated AWS cloud environment as part of OracleBio’s existing Quality Management Framework (QMF), providing a highly controlled and auditable environment for detailed and efficient image analysis.
Working to GCP with OracleBio allows you to generate quantitative image analysis data to a regulatory standard for clinical trial studies by running:
