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. 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 have recently launched GCP Image Analysis Services, the implementation of which was driven by Clinical Operations Manager, Alison Bigley. In this webinar, Alison will share insights from the GCP implementation journey and discuss:
- Key drivers in the implementation of GCP for Quantitative Image Analysis
- Why GCP is important and the benefits of working to GCP
- What is involved in conducting Quantitative Image Analysis Studies in accordance with GCP
Clinical Operations Manager
Alison Bigley is OracleBio’s Clinical Operations Manager and recently led the implementation of GCP services at the company. Alison previously spent 25 years at AstraZeneca, where she established and led a global digital pathology platform which included programming in proprietary software, application development and GxP validation. Alison has considerable experience in histology, immunohistochemistry and imaging on projects across various therapeutic areas involving pre-clinical, safety and translational medicine.
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