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P02: A Novel Partner Communication Gateway (PCG) to Enable Data Exchange and Reduce Operational Burden

Poster Presenter

Sandeepa Raina

Director, IT Business Partner, WorldWide Patient Safety
Bristol-Myers Squibb Company
United States

Objectives

The objective was to securely receive E2B transmission of individual case safety reports from business partners via extensible markup language (XML) format to enable automatic data extraction and receipt acknowledgment.

Method

The experiment involved processing XML files via email as true E2B files (R2), auto-extracting data via E2B from the XML, and attaching the source documents sent to the case created. Then, an auto-acknowledgment was sent to the sender for receipt items received via email or fax.

Results

This proprietary, in-house tool, the Partner Communication Gateway (PCG), was developed and validated within 4 months and implemented 2 months later. All functionality of the PCG was tested using a sample of 75 XMLs along with Council for International Organization of Medical Sciences (CIOMS) forms sent from email addresses pre-registered as valid senders prior to PCG implementation. Since January 2019, using the PCG, we have processed over 2,000 E2B files successfully, saving on case processing times. We have also sent over 150,000 acknowledgments to contract pharmacies, eliminating the time spent on manual reconciliation.

Conclusion

Based on safety data exchange agreements, there are partners with whom individual case safety data needs to be exchanged. These partners can generate XMLs, but because they often work with CROs they do not have a dedicated gateway to send XMLs (but can send via email). XML is the preferred format of data exchange when possible because it reduces manual data entry and therefore lessens human error. XML is both machine-readable and human-readable, allowing for automated exchange of information that may be reviewed, and quality checked by a pharmacovigilance subject matter expert. In addition, there is a need to perform reconciliation with contract pharmacies and business partners for cases received. This is a manual and quite a burdensome process. The PCG tool is able to transform the receipt of partner cases via E2B instead of CIOMS, by reducing manual data entry. The need to perform burdensome reconciliation activities is also eliminated because auto-acknowledgments are sent in real-time and include references to the case numbers and the dataset that is created. The PCG tool bridges the gap of receiving XMLs from partners via email and also addresses the limitation of sending source documents with E2B files, as E2B R2 does not support embedded attachments. The need to acknowledge the successful receipt of data was met. Overall, the use of the PCG tool has increased efficiency and reduced the operational burden associated with the reconciliation of individual case safety reports.