Global pharmaceutical company achieves industry-leading compliance in patient safety reporting

Published on 06 Feb 2023

Cloud, compliance, management, solutions

A culture in which patient safety is the foremost priority and reporting is never late may be enabled by regulatory compliance solutions that are founded on analytics and paired with insight into market research and patient support programs.

Our pharmaceutical customer, a significant worldwide conglomerate, needed help in maintaining global safety reporting compliance. Through a collaborative effort, we were able to identify the following factors as primary contributors to late cases:

  • "Lack of insight into when marketing, promotional, and patient support activities started and completed throughout the globe," and "the resultant predicted rise in adverse event reports that our client expected to receive by product and area."
  • Need for insight into the individual case safety report (ICSR) submissions made by licensing partners compared to the pharmacovigilance agreement (PVA) schedules. More personnel was necessary to handle the reports promptly once they were received for submission, with reduced turnaround times.
  • There is a lack of predictive methods for projecting ICSR's daily patterns and volume swings, making it difficult to provide enough personnel.

Our client made eliminating the possibility of late cases a priority to ensure that compliance deadlines were met and that any emerging signals affecting patient safety would be identified as quickly as possible. This was done to ensure compliance deadlines were adhered to and any emerging signals affecting patient safety would be identified.

Creating a zero-late-case culture

In its capacity as the valued client's strategic safety and technology partner, Cognizant was able to recognize and address any emerging ICSR compliance concerns. We devised a plan of action and put it into action to construct a zero-late-case culture methodically. Among our most important undertakings were the following:

  • Establishing a repository for market research and patient support programs (also known as MRPSPs) and developing automated alerting technologies to monitor MRPSPs. Our customers can more accurately predict when and where ICSR volume increases are likely to occur due to this. More than 400 clinical and commercial experts throughout the organization are presently using the application to monitor geographic areas that have been launched promotional campaigns, patient support programs, and post-market surveys. Users are alerted in an automated manner whenever applications begin or finish running.
  • Constructing an automated platform for tracking cases to prioritize each case according to its compliance timeframe. This significantly increases insight into the case process and enables efficient case prioritizing, which allows for the effective escalation of any ICSRs with approaching deadlines.
  • Using process analytics to determine whether license partners are taking an excessively long to file ICSRs, jeopardizes our client's ability to fulfill reporting deadlines. We do this by releasing a report every month.

Our customer achieved an industry-leading compliance rate of 99.98% by implementing these measures, which resulted in a compliance rate improvement of 3% overall. Even though additional products have been introduced via business acquisitions and collaborations, and ICSR volumes have climbed by an average of more than 30% per year over the previous two years; the firm has maintained its zero-late-case mentality.


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