Automating request processing to drive transparency and speed.

Automating request processing
to drive transparency and speed.

Client type:

Pharmaceutical.

Geography:

European Union.

Lifecycle stage:

Post-marketing.

Service area:

Regulatory Affairs.

Summary.

  • Providing transparency on request status, time spent on each request, speeding processes and reducing error.

  • Arriello developed a processing automation tool that would make the process of regulatory requests more transparent.

  • Our team took an innovative approach to developing a processing automation tool to meet specific KPIs.

Challenges.

The main issue was that regulatory affair (RA) request were being processed via e-mail. RA requests range from requests relating to dossier translation, through to artwork review and fees management. E-mail processing risks key communications being delayed. Monthly reconciliation of requests made and responded to was also time-consuming.

An automated solution was vital as the workload was heavy – around 1,300 e-mails were processed every month. Several vendors were involved in the chain of communications. It was important that they all bought into the need for change and improvement.

There was a clear requirement for more transparency on the status of requests and the time spent on each request. The challenge was to provide this information and improve the speed and accuracy of the regulatory requests process across five countries.

Solution.

Our innovative team was able to save the client time and money by working with a recently implemented software solution. Using Smartsheet, software used for project management and reporting, we developed a solution with automated communication flows, time reporting and reminders – and real-time transparency of each request. It also enabled us to consolidate all communication and documentation regarding one request in one place, under a unique ID.

Our team mapped out user flow, looking at how requests were handled and by whom, and who needed to be notified of which step. We developed all the potential scenarios during each request processing step and designed a solution to make sure KPIs are met and risk is minimized. We also trained a network of five vendors on the solution and we provide ongoing refresher training.

Now, there is less e-mail communication, better transparency and fewer errors – and KPIs for accelerated RA request processes are being met. Now, there is less e-mail communication, better transparency and fewer errors – and KPIs for accelerated RA request processes are being met.

Faster. Better. Smarter.

Arriello’s faster, better, smarter approach, allowed our client to quickly achieve their objectives for more transparency and more effective RA request processing. Our smart and innovative approach of tweaking a solution already in place provided a cost-effective solution that boosted return on investment on the client’s current platform.

Our proactive team put in place a solution that is now driving better KPIs for all stakeholders. Arriello’s cloud-based platform proved the smarter way to process requests transparently and much more efficiently.  

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