IMAGING CORE LAB
Combining advanced technology with deep expertise for precise, reliable imaging study results.
Our imaging core lab combine advanced technology with deep expertise to deliver precise and reliable results for imaging reader studies. This enables informed decision-making and accelerates clinical development. Through compliant electronic data capturing systems, we efficiently gather study results and prepare data for successful regulatory submissions.
Imaging Core Lab Services:
By leveraging cutting-edge imaging techniques, we provide high-quality data that meets rigorous standards. Our team is dedicated to maintaining the integrity and accuracy of the imaging data, which is crucial for regulatory compliance and the overall success of clinical trials. With our support, clients can be confident that their imaging studies are handled with the utmost care and precision.
Reader Study Protocol Development and Consultation
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Designing imaging protocols tailored to specific clinical trial needs.
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Providing expert consultation on imaging strategies and best practices.
Reader Training and Qualification
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Training and certifying imaging readers to ensure consistency and accuracy.
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Conducting reader performance monitoring and requalification as needed.
Imaging Data Management
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Implementing secure and compliant systems for storing and managing imaging data.
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Provide end-to-end services for collecting clinical cases and preparing them for imaging reader studies, ensuring accurate and organized datasets for thorough analysis.
Image Analysis and Interpretation
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Conducting centralized image analysis by trained radiologists or imaging specialists.
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Utilizing advanced software and AI tools for quantitative analysis.
Blinded Independent Central Review (BICR)
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Providing blinded independent review of images to minimize bias.
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Ensuring adherence to predefined criteria and protocols.
Regulatory Compliance and Submission Support
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Ensuring all imaging processes and data comply with regulatory standards (e.g., FDA, EMA).
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Preparing and submitting imaging data and reports for regulatory review.
Quality Assurance and Control
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Implementing quality control procedures to maintain high standards.
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Conducting regular audits and reviews to ensure compliance and accuracy.
Data Analysis and Reporting
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Performing statistical analysis of imaging data.
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Generating detailed reports and summaries for regulatory submissions and study endpoints.
Project Management
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Coordinating all aspects of imaging studies, from planning to execution.
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Ensuring timelines, budgets, and quality standards are met.
Technical Support and Troubleshooting
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Providing ongoing technical support for imaging equipment and software.
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Addressing any issues that arise during the trial promptly and effectively.
Communication and Collaboration
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Facilitating communication between sponsors, imaging sites, and regulatory bodies.
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Promoting collaboration to ensure the success of the imaging component of the trial.
