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Core Imaging Lab

Innovating affordable, AI-integrated medical devices that redefine healthcare accessibility and precision across clinical environments.

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Overview

Clinical Imaging Core Lab — Therapeutic Coverage & Controls

A multi-specialty imaging lab backing vascular, cardiology, neurology, and orthopedics studies with advanced modalities, ISO-aligned quality systems, and tightly managed data flows.

CapabilityWhat it delivers
Cross-specialty expertise Protocols tuned for vascular, cardiac, neuro, and ortho trials so reads stay clinically relevant and consistent.
Advanced imaging & analytics Use of high-end modalities and quantitative assessments to keep endpoints precise and repeatable.
QMS with ISO-aligned rigor Standard quality management practices that mirror ISO expectations for medical devices, keeping deliverables inspection-ready even without a formal core-lab certification.
Medidata image logistics Image uploads, query handling, and chain-of-custody tracked in Medidata for real-time transparency.
Synchrony read database Dual-review workflow and data entry locked in Synchrony, giving traceable adjudications and faster database locks.
Imaging Core Lab Process

From Start-Up to Closeout

Our core lab runs beside your trial from day zero to database lock—compressing timelines and keeping image data trustworthy end to end.

StageWhat we doWhat you receive
1. Start-Up Review the protocol, define imaging endpoints, draft submission/transfer guidance, co-build CRFs with your team. Study-specific imaging playbook and CRFs tailored to required data points.
2. System Set-Up Configure Medidata for secure uploads and query tracking; convert and validate CRFs inside Synchrony; train sites. Live image transfer environment with trained sites and validated electronic forms.
3. Collect & Analyze Dual-reader review for accuracy and quality; data entry and locks managed in Synchrony with audit trails. Clean, adjudicated reads with traceable reviewer decisions.
4. Export / Closeout Package final datasets to your preferred format or feed directly into your EDC; reconcile queries before lock. Ready-to-ingest imaging datasets that align with the sponsor database and inspection needs.

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