Transmission of safety data from OC/RDC to Argus

Infosys-Oracle practice: Transmission of safety data from OC/RDC to Argus
In the life sciences industry, enterprises often face challenges in collecting, monitoring, and analyzing diverse data across clinical development
and safety processes. Linkage between clinical data management and drug safety systems is of great importance from a compliance and
business perspective. Infosys has defined a structured and planned approach of integration and migration of Serious Adverse Event (SAE) data
between safety and clinical data management systems. It consists of predefined mappings between certain source systems; custom Extract,
Transform and Load (ETL) routines for automating data transformation and migration, backed by comprehensive validation resources.
In order to conclusively identify the
synchronized. Ensuring this requires manual
intensive process, and the likelihood of
safety profile of a drug, it is necessary
reconciliation of adverse events recorded
errors creeping in makes this process even
to ensure the safety system and clinical
across Argus and OC. Manual identification
more challenging.
data management systems are well
of cases needing reconciliation is an effort
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Solution overview
Infosys has developed a solution to
dynamically and contemporarily across • Avoid duplicity in data entry and integrate the safety data between OC/RDC
various systems.
manual reconciliation across systems thereby reducing the overall maintenance cost.
and Argus, which helps:
• Update and maintain the safety • Make Argus Safety a single source of data of a pharmaceutical product Solution benefits
• Removes dependency on other applications for all adverse events-
related information as Argus becomes the single source of truth for drug safety information.
• Creates a simple interface between OC and Argus with minimum or no additional infrastructure cost:
truth for all drug safety related information.
- Includes ETL to extract and process case data from Oracle clinical
- Offers XML generator that helps create cases in the required XML format readily accepted by Argus interchange
- Uses scheduler for running batch jobs
at required intervals of time
streamlined processes. Significant
reduction in time spent in overall case
processing and reporting.
• Extends the solution to establish a
framework for SAE data migration from
legacy system to Argus in a timely, highquality, and cost-effective manner with
complete validation.
• Reduces time to market due to
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