Download Multiple Safety System Integration

Technology Consulting Associates, LLC ● 5887 Glenridge Drive Suite 140 ● Atlanta GA 30328 ● Phone 404.303.1795 ● www.tca-llc.com
Technology Consulting Associates
experience
multiple safety system integration
A fundamental requirement facing life sciences companies is to provide the data required
to meet or exceed regulatory requirements. Today, that data must be electronic and
capabilities must be in place to ensure the transmitted data is secure and trustworthy.
Meeting regulatory commitments via electronic data transmission is further complicated
by the use of diverse safety systems (e.g., ARISg, Clintrace), the use of different
electronic protocols and gateways, and the need to meet the reporting requirements of
different regulatory agencies.
A multi-national Clinical Research Organization (CRO) needed a drug adverse event
reporting system to electronically submit Individual Case Safety Reports (ICSR) to the
U.S and European regulatory agencies. This CRO serviced clients with differing safety
systems, that is, the Argus and the Clintrace safety system. Both vendors of these
systems had electronic reporting solutions, but the CRO did not want to purchase,
implement, and use two electronic reporting solutions.
vision
TCA recommended the use of a TCA developed software package
called Distribution Center (DC) to provide the required data extraction,
transformation, and loading (ETL) capabilities. In addition to ETL, this
package provided capabilities to normalize adverse event data from
multiple safety system databases and submit electronic reports to the
required regulatory agencies.
experience
TCA has extensive experience in the life sciences industry and niche
expertise with the major safety system databases including Argus™,
Clintrace™, ARISg™ and proprietary databases.
results
DC was installed and configured to extract and normalize data for
reporting purposes from both Argus and Clintrace. In addition, DC
provided the required regulatory submissions to regulatory authorities.
This solution has been in continuous operation for years.
value
Accomplishing the integration with a single gateway and
implementation, the CRO saved time, money, administration, and
training. This allowed for rapid ROI realization and created a new
revenue stream.