Life sciences companies have many regulatory responsibilities. This includes the obligation to document and maintain consumer feedback on the safety and efficacy of their products. When a large life sciences company saw that obligation increasing exponentially, with the volume of Individual Case Safety Reports (ICSR) doubling year over year, they turned to us to help them design an automated solution.
RPA replaces manual process
We saw an opportunity to introduce RPA, which is proving to be extremely effective in environments that rely on manual, rule-based processes. In developing the RPA solution, we saw it as a first step in introducing automation that can be utilized in other areas of the organization.
We started with an important but relatively simple part of the ICSR process involving the electronic transfer of data, known as E2B transmissions. Our team designed and implemented BOTs that automate the sorting and data-entry stages of the E2B transmission.
Immediate results, and scalable
While the immediate goal of the project was to replace and automate repetitive manual activities with a “0-touch” RPA solution for the processing of Individual Case Study Reports, the long-term goal however, was more far-reaching.
That part required careful planning. First, we had to ensure that the solution would stand up to regulatory scrutiny. If and when regulators wanted to inspect the reports, would the company be able to make them available immediately in the form the regulators required?
Second, we needed to ensure that it was scalable, so we could expand process automation to other areas of the organization. To ensure inspection readiness, we adopted a rigorous approach, testing, documenting and validating the BOTs in three phases comprising 300+ test cases. Building a scalable solution meant a modular approach, which can be customized as needed. The modular approach also enables faster deployment, which will allow the company to respond rapidly to change in the always-evolving life sciences industry.
Faster processing, fewer errors
The RPA solution was completed and went live in just seven months. New automation efforts are in development to incorporate areas where more complex processing is needed along with certain cognitive elements including artificial intelligence and machine learning.
The benefits so far? 30 percent reduction in end-to-end cycle time, improvement in first-time accuracy from 85 percent to 99 percent, improvement in regulatory compliance from 95.7 percent to 96.12 percent, and improved turnaround time compliance from 88.6 percent to 91.9 percent. More important though, its modular design can be customized and scaled for future needs for other types of documents and transmission modes.