Business Case detail

Local Pharmacovigilance Management

Project: Local Pharmacovigilance Management

Client: Global Pharma Company, United States

Summary: Local PHV support in 14 EU countries scaling up to 80 countries.  Local PHV support – local QP, local literature searching, ICSR processing, dealing with the local HA, regulatory intelligence.  

In 2009, this client chose Arriello to be the partner for outsourcing of some of their EU Pharmacovigilance activities, both local and global.  By employing our services, the client was able to benefit from having one point of contact for 14 EU countries for all the local PHV needs – local QP contact, local literature searching, case processing, local regulatory intelligence and support with any ad-hoc regulatory submissions/filing.  We helped to save the client time and money and maintain a level of consistency by providing excellent Vendor Management. 

The client wanted to expand the number of countries and regions from EU to global so that they could harmonise their local Pharmacovigilance support across all countries where their product was present under one vendor. 

Issues: The expansion plans meant that we needed to address how we would efficiently manage so much information in a streamlined manner.  14 countries had been managed by email communication via one Project Manager.  However, we felt that it was necessary to use a much more advanced system for so many more countries.    We also need to ensure that we kept management simple for us, as the vendor, and for the client.  Lastly, we wanted to ensure uniformity of delivery from every vendor.

Solutions we gave:

The expansion plans meant that we needed to address how we would efficiently manage so much information in a streamlined manner.  14 countries had been managed by email communication via one Project Manager.  However, we felt that it was necessary to use a much more advanced system for so many more countries.    We also need to ensure that we kept management simple for us, as the vendor, and for the client.  Lastly, we wanted to ensure uniformity of delivery from every vendor.

Our proposed Offering: We began by addessig the key concern of our client – namely the centralized and efficient management of vendor data in a coordinate manner.  Our original offering base upon listening to what the clients preference was, was to have a bespoke SharePoint system for this project.  We drafted a schematic how the system could look and the workflow between the client, us and every vendor (around 80 in total).  We then conducted a number of face to face meetings to present and discuss the options. 

It became apparent that there was a better solution for the client – utilizing our own cloud based system to manage data from all stakeholders.  This system comprised of modules that allowed for vendors to load information in the same way without being able to see each other’s actions.  On, the other hand, the system allowed us and the client to have complete oversight.  Within that, we built in several workflows with approval processes that involved the client and us.  The result was a system that made a complex project manageable and in the cloud.

Conclusion

We worked together to eventually put together a system that worked for everyone – client, Arriello and the vendors (which was key).  The system was then used as a benchmark for other such projects and has been incredibly successful in being rolled out in minimum time.