Technological Advantage
RadPharm is committed to invest in on-going innovation and continuous upgrades to our system architecture to ensure we are applying the most advanced technological solutions for medical image assessment services in the market today. Many of our proprietary digital imaging solutions are configured or developed in-house, and are managed, maintained and enhanced by RadPharm’s technology professionals.
This affords us the timely ability to provide the specific data and workflow requirements necessary to support imaging core lab functions and required FDA processes - including the sequential un blinded locked read paradigm, mandated by the FDA.
From the moment an image arrives in-house through to study-close out and database archiving, RadPharm employs 21 CFR part 11 compliant platforms to receive, track, blind, manage, review, submit and archive medical imaging media and data. Our cutting-edge technology, combined with our regulatory, medical and operational expertise guarantees we introduce operating efficiencies into every study – thereby ensuring time and resource savings.
Systems Overview
 RadPharm’s proprietary system is a comprehensive platform that allows tracking, management and reporting of digital medical imaging media in a stringent quality-controlled environment. Real-time user access is assured.
- Web based, real-time, multi-user client-server application
- Robust, paperless system
- Tracks media from receipt to read
- 15 standard reports on clinical trial, including:
- Media Receipt (exams, missing time points)
- Open issues
- Site status
- MCC Metrics
- 21 CFR Part 11 compliant
Oracle Clinical v 4.5.1
Oracle Clinical (OC) - Oracle Clinical, the most ubiquitous data management platform in life sciences, offers RadPharm partner sponsors reassuring familiarity with data management, transfer and reporting processes.
Data generated during image review is collected in Oracle Clinical and is quality reviewed programmatically and manually. Programmatic edit checks are study-specific and are tested and validated fully prior to deployment in OC. Sponsors are able to review and comment upon data quality specifications prior to study deployment.
Digital Media and Image Reading Systems
 Image Repository System CVS - System provides version control, audit trails, check in/check out capabilities. Stores measurements as well as images.
DIS – Custom de-identification system used to remove identifying information,
add clinical trial identifiers, sanitize DICOM headers and store images within
the repository.
Work List Maker (WLM) – Validated tool used to select and assign sets of images as tasks for review by reader. Supports blinded and sequential
locked reads.
MedStudio – Customized reading tool used to calibrate, annotate and
measure lesions on images. Access to repository is strictly under work list
control.
 Internet Media Transfer (IMT)
- Provides a real-time secure method to transfer images from the imaging site directly to RadPharm
- Simple drag-and-drop process to transfer file to RadPharm
- Only Internet access needed - No special site configuration, hardware, install permissions or connections needed
- Eliminates courier costs
- Based on HTTP-based WebDAV protocol (Windows ‘98+ or Mac)
- 128-bit SSL security (HTTPS)
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