AG Mednet storage services provide a seamless mechanism to store clinical trial image data. Developed from the ground-up to be a robust, Part 11 compliant repository, our storage solutions are an ideal complement to AG Mednet’s quality enhancement products.
Several audiences can utilize this solution:
You’re a successful academic lab where, in addition to the capital expenditures required to purchase hardware and software, you get charged continuous hosting and management fees from the university IT department, even when you don’t have an active trial taking place. You must maintain the systems you purchased in a validated state, including proper SOPs for software and hardware change control, back up, redundancy, trace matrices and security so that you can respond successfully each time you are audited. For this reason, you have chosen to use a system based on physical CD/DVDs and viewing software that is used exclusively to perform analysis and measurements.
Why AG Mednet Storage?
Use AG Mednet with integrated storage to collect, QC and store image exams. Review your image data using any of our available options: the AG Mednet viewer, your own WADO compliant viewer, or download your DICOM images directly into your local workstation. Working in concert with the AG Mednet network, you will have real-time notifications as soon as new data is received, and through our Portal you have access to a rich worklist of available image exams and relevant Case Report Forms submitted by trial sites.
You are a core lab with investments in infrastructure, and you have been storing image data electronically. You would prefer to focus your investments on improving core lab operations but your growth requires you to continually scale your available storage infrastructure, adding more capital investments and requiring increasing manpower to maintain, upgrade and validate while providing redundant storage to your operations team. You would prefer to outsource all or part of your infrastructure to lower operational costs.
Why AG Mednet Storage?
If you are one of the more than 25 core labs already using AG Mednet to collect and deliver timepoints to your repository, you can use our storage offerings for redundancy and long-term archival. If you have geographic constraints for your data, such as having to store it in the European Union because of regulations, AG Mednet can provide you with regional storage in multiple locations in Asia, Australia, South America, Europe and the US. You can use AG Mednet to achieve your redundancy, availability and disaster recovery requirements, as well as to help manage remote access to images by outside readers. Since AG Mednet can simultaneously deliver image submissions to multiple locations, copies of every exam can flow directly to both your in-house repository and AG Mednet’s redundant storage or long-term archive. AG Mednet can therefore provide you with on-demand infrastructure expansion without increased capital or FTE investments.
You are a sponsor running a trial with image submissions going to different core labs depending on modality. Your internal principal investigators are eager to see some of the data in real time, and you would like to provide them with a single, consistent method to view image timepoints and case report forms independent of the core lab that receives them. In addition, at the end of the trial, you would like to have a single repository with all the image submissions that were sent by sites during the trial. You might simply archive this data for future viewing or you might want to aggregate it to enable future retrospective analysis of image subsets you received during your projects. The internal development of this infrastructure is not currently a practical project, but you still need a way ensure that the investment you already made to scan subjects and QC submissions and deliver this data to core labs does not get lost.
Why AG Mednet Storage?
AG Mednet provides you on-demand, secure, validated and scalable infrastructure to collect copies of the image data and case report forms directly from sites that are delivered simultaneously to your core labs. For those submissions that might arrive via courier, the timepoints can be uploaded by your core labs via the Desktop Agent, or directly from their repository, after receipt. Your internal study teams can be automatically alerted when new images are sent by sites, and they have real-time access to the submissions. Instead of having one image database per core lab, your teams will have all the data aggregated in a way they can query it by site, subject, timepoint and modality, among others. At the end of the trial you will have copies of all the unaltered submissions which you can archive for future use and aggregation with other trial submissions.
AG Mednet Storage Benefits:
- We validate and maintain the systems compliance with regulations
- We maintain and upgrade the infrastructure
- We do backups and worry about redundancy
- No capital investment is required
- Storage can be accurately budgeted when sizing the trial
- Sites can continue to use AG Mednet as their standard method of assembling and submitting image data
- Provides the benefit of AG Mednet automated quality assurance tools
- Query storage repository using parameters including site, subject and visit
- Get real-time access to images and eCRFs
- Enjoy long-term archival capabilities