LIFE SCIENCES
Analytics-Driven Solution Helps Improve Regulatory Compliance Rate For Pharma Firm
The Challenge
A global pharmaceutical company wanted to overcome the complexities of regulatory compliance worldwide. The lack of visibility into the timelines of its marketing, patient support programs and licensing partners’ individual case safety report (ICSR) submissions resulted in late case submissions. The company decided to focus on eliminating these issues to ensure adherence to its deadlines and identify emerging signals affecting patient safety. It approached ACS life sciences technology experts to improve visibility into processes as well as market research and patient support programs (MRPSPs) to create a zero-late-case culture.
Our Approach
As the client’s strategic safety and technology partner, we started by identifying any ICSR compliance issues as they emerged. We developed and implemented an action plan to systematically build a zero-late-case culture. First, we focused on creating an MRPSP repository and automated notification tools to track these programs to help predict when and where ICSR volumes are likely to increase. Next, we built an automated case tracking tool to prioritize each case by its compliance timeline, leading to improved visibility into the case workflow. Finally, we applied process analytics to identify licensing partners that are slow to submit ICSRs and jeopardize the company’s ability to meet its reporting deadlines.
Initiatives Drive Industry-Leading Compliance Performance and Increase ICSR Volume
ACS helped the company achieve an industry-leading average regulatory compliance rate of 99.98%. Additionally, we helped the client maintain compliance performance while increasing ICSR volume by an average rate of 30% annually. We also assisted in removing late cases and helped build an environment where patient safety is paramount.
99.98%
average regulatory compliance rate
Helped create
zero-late-case culture
30% annual increase
in average rate of ICSR volume
