Imaging plays a pivotal role in determining the progression and success of therapeutic development. It measures the safety, efficacy, and biological impact of new therapies.
Imaging endpoints have become increasingly essential in therapeutic areas such as oncology, neurology, and musculoskeletal disorders. Core Labs have emerged as indispensable partners in delivering compliant, and globally scalable trial outcomes.
Image Core Lab specializes in supporting global trials with standardized, centralized imaging services, ensuring consistent reads, regulatory-ready data, and scientifically sound endpoints.
What is an Imaging Core Lab?
An Imaging Core Lab is a centralized facility that oversees the acquisition, quality control, and interpretation of imaging data for clinical trials. These labs ensure consistency, quality control, regulatory compliance, and independent assessments of imaging endpoints.
Core Labs allow communication and data-sharing hub between:
- Biopharmaceuticals
- Life Science Companies
- CROs
- Medical device Companies
This supports multi-center and multi-geographic trials, ensuring imaging integration into the broader clinical research workflow.
Why Sponsors Choose Core Lab Services
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Global Clinical Trials Are Becoming More Complex
With the clinical trials market projected to exceed $115.65B by 2034, standardization across trial sites has become non-negotiable.
Imaging variability, site readiness, inconsistent acquisition protocols and reader bias can delay timelines and undermine data integrity.
Image Core Lab help mitigate this risk by:
- Developing and standardizing imaging protocols
- Conducting site qualification and technologist training
- Enabling centralized, blinded image interpretation
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Consistency Across Global Clinical Trial Sites
One of the core functions of core labs is to safeguard the quality and consistency of imaging data across all participating trial sites.
Image Core Lab ensures that consistency by:
- Real-time quality checks and flagging deviations
- Seamless coordination with site technologists and investigators
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Quality Assurance and Regulatory Compliance
Every image processed by a core lab must adhere to regulatory standards. ICL’s processes and platform are aligned with:
- GCP
- FDA 21 CFR Part 11
- EMEA and HIPAA
Image Core Lab’s Proprietary platform, CLINSpa offers built-in regulatory compliance minimizing risk while maximizing confidence in the data.
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Workflow Streamlining & Cost Efficiency
Centralized image management simplifies collaboration across sponsors, CROs, investigators, and regulatory authorities. With 24/7 access via CLINSpa, stakeholders can:
- Review reads and adjudications in real time
- Resolve queries faster
- Reduce turnaround times
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Data Security and Patient Privacy
With the sensitive nature of patient imaging data, Imaging Core Labs must operate under robust data privacy frameworks.
Image Core Lab employs
- Advanced anonymization protocols
- Encrypted data transfer mechanisms
- Controlled user access within the CLINSpa platform
Image Core Lab vs CRO Imaging Services
| Feature | Image Core Lab | CRO Imaging |
|---|---|---|
| Primary Focus | Solely dedicated to imaging interpretation in clinical trials. | Imaging is one vertical among many; attention is divided across services. |
| Subspecialty Radiology Reads | ✔ | ✖ Often Generalist |
| Blinded Independent Reads | ✔ | ✖ Often internally with potential bias |
| Regulatory Imaging QC | ✔ | Limited |
| AI Validation Support | ✔ | ✖ Rare |
| Radiology Workflow Platform | ✔ Proprietary CLINSpa platform | ✔ Varies, depends on third-party or generic systems |
Trusted Imaging Core Lab for Biopharma and MedTech
Sponsors today demand more than routine reads. They need an imaging partner that brings consistency, regulatory confidence, and scientific precision to every trial.
We deliver this with:
- Full-spectrum imaging support from protocol design to regulatory submission
- Site management with staff training, QC workflows, and operational support
- Expert subspecialty radiologists with trial-specific experience
- Integrated platform (CLINSpa) for real-time data tracking, annotation, and audit readiness
With deep therapeutic insight and operational agility, we help sponsors reduce imaging variability, ensure data reliability, and meet regulatory timelines with confidence.
Frequently Asked Questions
Why Centralized Imaging is Essential for Trials?
How does Image Core Lab help with regulatory submissions?
Does Image Core Lab support clinical trials in India and globally?
Can Image Core Lab support Radiology AI validation?
Yes. Image Core Lab plays a critical role in clinically validating radiology AI and SaMD (Software as a Medical Device) tools. We support the full lifecycle, from data annotation to ground truthing, MRMC studies, and technical validation.