AG Mednet Cloud Storage Solutions for Clinical Trial Data

Imaging clinical trials create a
tremendous amount of data – several gigabytes per subject – and require
storage for a minimum of seven years for regulatory compliance.

To support the need for storage and
streamlined access to data during and after a clinical trial, AG
Mednet Inc. announced AG
Mednet Storage – a Part 11 compliant repository with on-demand
access to clinical trial image data.

It is a complement to AG Mednet’s
quality enhancement products including AG Mednet Submission Quality &
Compliance – an automated quality assurance software built to
detect errors at the investigator site prior to data submission in
order to reduce queries and accelerate clinical trial
decision-making.

Specific benefits include:

For Sponsors

• Secure, validated and scalable
  infrastructure;

• Copies of image data and case report
  forms from sites delivered simultaneously to sponsors and core labs;

• Automatic alerts when new images are
  sent with real-time access to submissions;

• Aggregated data for querying by site,
  subject, timepoint and modality;

• On-demand access to post-trial copies
  of unaltered submissions for future use and aggregation with other
  trial submissions.

For Core Labs

• On-demand infrastructure scalability
  without increased capital or FTE investments;

• Redundancy, DR and long term archival;

• Management of remote access by outside
  readers;

• Regional storage across Asia,
  Australia, South America, Europe and the US;

• Simultaneous delivery of image
  submissions to multiple locations.

For Academic Core Labs

• Collect, quality control and store
  image exams through AG Mednet;

• Review image data using the AG Mednet
  viewer, WADO compliant viewers, or download DICOM images directly to
  local workstations;

• Real time notifications when new data
  is received;

• Access to a rich worklist of available
  image exams and relevant Case Report Forms submitted by trial sites.

"AG Mednet is committed to
providing technology solutions that enable breakthrough
pharmaceutical advances through zero-delay clinical trials,"
says Abraham Gutman, president and CEO of AG Mednet. "The
ability to easily store and access image data in a Part 11 compliant,
on-demand manner gives sponsors, CROs and AROs the flexibility to
expand current offerings and increase revenue opportunity with no
capital expense. When used with AG Mednet’s quality enhancement
offerings, organizations no longer need to accept trade-offs when it
comes to managing, storing and accessing clinical trial imaging
data."