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Imaging Core Lab Services for Medical Device Clinical Trials
Why Companies Choose NAMSA
320+
Medical Device or IVD Clinical Projects Each Year
230+
Clinical Professionals on Staff
1,700
Medical Device Clinical Trials Supported
12
Therapeutic Areas in Which NAMSA Has Experience
End-to-End Clinical Expertise
With technology at its crux and a dedicated team of world-renowned physicians at the helm, NAMSA offers the highest quality Imaging Core Laboratory services in the CRO industry. Our expert imaging reviewers ensure quality and accuracy of image interpretation and analyses, and our highly efficient processes leave little for sponsors to manage. We offer:
- End-to-end service from image transfer and database set-up to site training on image acquisition and transfer
- Study protocol review for imaging endpoints
- Seamless integration and leverage of systems across NAMSA
- Transparency at every step and real-time client access to data
- Industry-best image reviews and turnaround times
With zero FDA audit findings and ISO 9001:2015 accreditation our imaging core laboratory has reviewed over 12,000 images and supported 60% of all successsful PMA approvals by the US FDA last year.
Clinical Imaging Core Lab Therapeutic Areas We Support
NAMSA has extensive expertise in a wide range of therapeutic areas, including vascular, cardiology, neurology, and orthopedics. Our Imaging Core Lab utilizes advanced modalities and analyses to support these therapeutic areas, ensuring precise and reliable results. Operating under standard QMS and following ISO standards relevant to medical devices and quality management, our lab maintains high-quality standards despite not having specific core lab certifications. We use the Medidata image transfer system for tracking image uploads and queries, and the Synchrony database for tracking image reviews and data entry, providing robust imaging management solutions. By leveraging cutting-edge technology and a team of experienced professionals, we provide comprehensive imaging solutions that enhance the efficiency and accuracy of clinical trials.
Imaging Core Lab Process and Services
The NAMSA Imaging Core Lab solution supports your trial from the start-up phase all the way through to closeout. With our deep expertise, we drive efficiency and deliver best-in-class turnaround times that are unmatched by other Imaging Core Labs. Our comprehensive services ensure that every aspect of your trial is handled with precision and excellence, providing you with reliable and timely results.
Our high-level process is detailed below giving you an overview of our operations:
Process
| 1. Start Up Phase | 2. System Set Up | 3. Collect and Analyze | 4. Export Data |
|---|---|---|---|
| – Review clinical trial protocol to determine imaging and measurement needs. – Create imaging guidelines and transfer instructions with Medidata. – Develop CRFs with client to capture necessary data points. – Convert CRFs to electronic forms in the Synchrony database. – Validate CRFs for compliance and train personnel on data entry. | – Set up a customized web-based image transfer system via Medidata. – Train sites on image upload, query management, and tracking. | – Images reviewed by two reviewers for accuracy and quality. – Data entered into Synchrony database and locked after review. | – Export finalized data and provide it to the sponsor in the required format, or enter it into the sponsor’s EDC. |
Services
Image Management Transfer
Our Imaging Core Lab offers a seamless and secure Image Transfer service designed to support medical device clinical trials. This service ensures the efficient and reliable transfer of imaging data from clinical sites to our central lab, facilitating timely analysis and reporting.
Key Features:
- Secure Data Transfer: Utilizing advanced encryption protocols, we guarantee the confidentiality and integrity of your imaging data during transit.
- Compliance with Regulations: Our processes adhere to all relevant regulatory standards, including HIPAA and GDPR, ensuring your data is handled with the utmost care and compliance.
- User-Friendly Interface: Our intuitive platform allows for easy upload and tracking of imaging data, minimizing the burden on clinical site staff.
- Real-Time Monitoring: Continuous monitoring of data transfer ensures any issues are promptly identified and resolved, maintaining the flow of critical information.
- Technical Support: Our dedicated support team is available 24/7 to assist with any technical challenges, ensuring smooth and uninterrupted service.
By leveraging our Image Transfer service, you can be confident that your imaging data is managed with the highest standards of security and efficiency, enabling you to focus on the critical aspects of your clinical trials.
Image Management Transfer – Medidata
Our Imaging Core Lab offers a seamless and secure Image Transfer service designed to support medical device clinical trials. Leveraging Medidata’s advanced image transfer solutions, we ensure the efficient and reliable transfer of imaging data from clinical sites to our central lab, facilitating timely analysis and reporting.
Key Features:
- Secure Data Transfer: Utilizing Medidata’s state-of-the-art encryption protocols, we guarantee the confidentiality and integrity of your imaging data during transit.
- Compliance with Regulations: Our processes, powered by Medidata, adhere to all relevant regulatory standards, including HIPAA and GDPR, ensuring your data is handled with the utmost care and compliance.
- User-Friendly Interface: Medidata’s intuitive platform allows for easy upload and tracking of imaging data, minimizing the burden on clinical site staff.
- Real-Time Monitoring: Continuous monitoring of data transfer through Medidata ensures any issues are promptly identified and resolved, maintaining the flow of critical information.
- Technical Support: Our dedicated support team, in collaboration with Medidata, is available 24/7 to assist with any technical challenges, ensuring smooth and uninterrupted service.
By leveraging our Image Transfer service, supported by Medidata’s cutting-edge technology, you can be confident that your imaging data is managed with the highest standards of security and efficiency, enabling you to focus on the critical aspects of your clinical trials.
Image Analysis Review
Our Imaging Core Lab provides a comprehensive Image Review service tailored to support medical device clinical trials. This service ensures that all imaging data is meticulously reviewed and analyzed by our team of expert radiologists and imaging specialists.
Key Features:
- Expert Analysis: Our team of board-certified radiologists and imaging specialists bring extensive experience in clinical trial imaging, ensuring accurate and reliable interpretations.
- Standardized Protocols: We adhere to standardized imaging protocols and criteria, ensuring consistency and reproducibility across all reviews.
- Advanced Technology: Utilizing state-of-the-art imaging software and tools, we enhance the precision and efficiency of our reviews.
- Timely Reporting: Our streamlined processes ensure that image reviews are completed promptly, providing timely feedback to support your clinical trial timelines.
- Quality Assurance: Rigorous quality control measures are in place to ensure the highest standards of accuracy and reliability in our image reviews.
- Customized Reporting: We offer tailored reporting formats to meet the specific needs of your clinical trial, providing clear and actionable insights.
By choosing our Image Review service, you can be assured of high-quality, consistent, and timely imaging evaluations, supporting the success of your medical device clinical trials.
Syncrony Image Analysis System
NAMSA’s proprietary Syncrony software, developed by Syntactx, offers advanced image analysis capabilities tailored for medical device clinical trials. This powerful system enhances the precision and efficiency of imaging data analysis, providing critical insights to support your research and development efforts.
Key Features:
- Advanced Analytical Algorithms: Syncrony utilizes state-of-the-art algorithms and machine learning techniques to deliver detailed and accurate analysis of imaging data.
- Customizable Analysis Protocols: The system allows for tailored analysis protocols to meet the specific needs of your clinical trial, whether it involves complex anatomical regions or specific imaging modalities.
- High-Resolution Outputs: Syncrony provides high-resolution analytical results, facilitating detailed interpretation and reporting.
- Seamless Integration: The software integrates smoothly with various imaging modalities, ensuring a streamlined workflow from data acquisition to analysis.
- User-Friendly Interface: Syncrony’s intuitive interface allows for easy navigation and efficient data processing, minimizing the burden on clinical site staff.
- Regulatory Compliance: The system adheres to all relevant regulatory standards, ensuring that your data is handled with the highest level of care and compliance.
- Expert Validation: Our team of imaging specialists and radiologists validate the analysis results, ensuring high accuracy and reliability.
By leveraging Syncrony, you can achieve precise and reliable analysis of your imaging data, supporting the success of your medical device clinical trials and enhancing the overall quality of your research outcomes.
Imaging End Point Review
Our Imaging Core Lab offers a specialized Imaging End Point Review service designed to support the critical evaluation of imaging data in medical device clinical trials. This service focuses on the precise assessment of imaging endpoints, ensuring robust and reliable trial outcomes.
Key Features:
- Expert Review Panel: Our team comprises experienced radiologists and imaging specialists who are experts in evaluating clinical trial endpoints.
- Standardized Criteria: We utilize standardized criteria and protocols to ensure consistency and accuracy in endpoint assessments.
- Blinded Reviews: To maintain objectivity, our reviews are conducted in a blinded manner, minimizing bias and ensuring impartial evaluations.
- Advanced Imaging Tools: We employ cutting-edge imaging software and technologies to enhance the accuracy and efficiency of our endpoint reviews.
- Timely and Detailed Reporting: Our efficient processes ensure that endpoint reviews are completed promptly, with detailed reports that provide clear and actionable insights.
- Regulatory Compliance: Our service adheres to all relevant regulatory standards, ensuring that your trial data meets the highest quality and compliance requirements.
By leveraging our Imaging End Point Review service, you can ensure that your clinical trial endpoints are evaluated with the highest standards of accuracy and reliability, supporting the success of your medical device development.
Image Segmentation
Our Imaging Core Lab offers a specialized Organ and Tumor Segmentation service, crucial for detailed analysis in medical device clinical trials. This service focuses on the precise delineation of organs and tumors within imaging data, providing critical insights for your research and development.
Key Features:
- Advanced Segmentation Algorithms: We utilize cutting-edge algorithms and machine-learning techniques specifically designed for accurate segmentation of organs and tumors.
- Expert Validation: Our team of experienced radiologists and imaging specialists validate the segmentation results, ensuring high accuracy and reliability.
- Customizable Protocols: We offer tailored segmentation protocols to meet the specific needs of your clinical trial, whether it involves complex anatomical regions or specific tumor types.
- High-Resolution Outputs: Our service provides high-resolution segmented images, facilitating detailed analysis and interpretation of organ and tumor structures.
- Integration with Analysis Tools: Segmented images are seamlessly integrated with advanced analysis tools, enhancing the overall efficiency of your imaging workflow.
- Regulatory Compliance: Our processes comply with all relevant regulatory standards, ensuring that your data is handled with the highest level of care and compliance.
By choosing our Organ and Tumor Segmentation service, you can achieve precise and reliable delineation of critical anatomical structures, supporting the success of your medical device clinical trials.
Site Imaging Training
Our Imaging Core Lab offers a comprehensive Site Imaging Training service designed to ensure that clinical site staff are proficient in the imaging protocols and procedures required for medical device clinical trials. This service aims to enhance the quality and consistency of imaging data collected across all trial sites.
Key Features:
- Customized Training Programs: We develop tailored training programs that address the specific imaging requirements of your clinical trial, including modality-specific protocols and best practices.
- Expert Instructors: Our training sessions are led by experienced radiologists and imaging specialists who provide in-depth knowledge and hands-on guidance.
- On-Site and Remote Training: We offer flexible training options, including on-site visits and remote sessions, to accommodate the needs of your clinical sites.
- Comprehensive Training Materials: Participants receive detailed training materials, including manuals, checklists, and video tutorials, to support ongoing learning and reference.
- Quality Assurance: Our training programs include quality assurance components to ensure that imaging procedures are performed consistently and accurately across all sites.
- Continuous Support: We provide ongoing support and refresher training as needed, ensuring that site staff remain proficient throughout the duration of the clinical trial.
By utilizing our Site Imaging Training service, you can ensure that your clinical trial sites are well-prepared to collect high-quality imaging data, contributing to the overall success of your medical device clinical trials.
Screening Review
Our Imaging Core Lab offers a comprehensive Screening Review service designed to support medical device clinical trials. This service ensures that all imaging data collected during the screening phase is meticulously reviewed and assessed for eligibility and baseline characteristics.
Key Features:
- Expert Review Panel: Our team of experienced radiologists and imaging specialists conduct thorough reviews of screening images, ensuring accurate and consistent assessments.
- Standardized Criteria: We utilize standardized criteria and protocols to evaluate imaging data, ensuring consistency and reliability across all reviews.
- Timely Assessments: Our efficient processes ensure that screening reviews are completed promptly, providing timely feedback to support patient enrollment and trial timelines.
- Detailed Reporting: We provide comprehensive reports that include detailed findings and recommendations, facilitating informed decision-making for patient eligibility.
- Quality Assurance: Rigorous quality control measures are in place to ensure the highest standards of accuracy and reliability in our screening reviews.
- Regulatory Compliance: Our service adheres to all relevant regulatory standards, ensuring that your data is handled with the utmost care and compliance.
By leveraging our Screening Review service, you can ensure that your clinical trial starts with accurate and reliable imaging assessments, supporting the success of your medical device development.
Imaging and AI Validation
Our Imaging Core Lab offers a specialized Imaging and AI Validation service designed to support medical device clinical trials. This service ensures that imaging data and AI algorithms used in your trials are rigorously validated for accuracy, reliability, and compliance with regulatory standards.
Key Features:
- Expert Validation Team: Our team of experienced radiologists, imaging specialists, and AI experts conduct thorough validations of imaging data and AI algorithms, ensuring high standards of accuracy and reliability.
- Advanced Validation Protocols: We utilize advanced validation protocols and methodologies to assess the performance of AI algorithms in analyzing imaging data.
- Regulatory Compliance: Our validation processes adhere to all relevant regulatory standards, including FDA and EMA guidelines, ensuring that your AI algorithms and imaging data meet the highest compliance requirements.
- Comprehensive Reporting: We provide detailed validation reports that include performance metrics, findings, and recommendations, facilitating informed decision-making for your clinical needs.
- AI-Based Biomarket: We assist with the development of AI biomarkers or validation of existing AI biomarkers used for screening and disease progression predictions.
By leveraging our Imaging and AI Validation service, you can ensure that your imaging data and AI algorithms are validated with the highest standards of accuracy and compliance, supporting the success of your medical device clinical trials.
Meet Our Clinical Experts
Explore the depth of our team’s expertise in clinical study reporting.
-
Adam Saltman, PhD, MD
Chief Medical OfficerView Bio -
Kenneth Ouriel, MD, MBA
EVP and KOL Managing DirectorView Bio -
Jeff Geschwind, MD
Medical Director–Oncology, Image-Guided Therapy, and Imaging Core LabView Bio -
Pedro Eerdmans, MD, PhD
Director, Global Strategy ServicesView Bio -
Tawnya J. Meier, MD
Associate Medical Director, SafetyView Bio -
Thomas Vanderveken, MD
Associate Medical DirectorView Bio
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