In early 2010, Ashfield formed a partnership with a global consumer brands company (consumer care, cosmetics, device, and soap/household cleaning). This relationship continues today.
Ashfield provides full service pharmacovigilance activities for this client to include case processing, literature searches, medical review of ICSR’s; aggregate report writing, medical review and pharmacovigilance consulting services. We also provide ICSR and aggregate report submissions for drug/device/consumer products as well as signaling/trending activities. We have helped this client re-register products in the EU Medicinal Products database. Ashfield provides all of this work domestically with no offshore support.
This company has a wide array of over 1000 products and faced numerous challenges with their pharmacovigilance activities. The company has consumer products that are considered “drugs” due to active ingredients. However, some products are designated as “drugs” in some countries and as “devices” in other countries, creating confusion.
At time of on-boarding with Ashfield, our client had been doing manual entry of AE reports onto a MedWatch form rather than using a safety database. All of these were completed on Excel spreadsheets and required manual completion and submission of MedWatch forms, creating a cumbersome, paper driven process. For several years, Ashfield worked with the client to maintain this paper driven process while sharing suggestions for improvement to the processes that would generate efficiencies and increase quality. During this time, we identified that roughly 6000 paper legacy cases had to be entered into a safety database for PADER or PSUR reporting and source documents were not consistent. Their call intake center was used for all calls, but the call communicators had no specific AE training so AE intake information was inconsistent and discrepant resulting in the frequent follow-up requests. Overall, the processes were inefficient and unnecessarily expensive for the client.
Ashfield became actively involved in developing and implementing process improvements. Training was provided to call center communicators to enhance understanding of the importance of AE data and to assist the development of improved AE intake processes. Ashfield supported the client’s QPPV by providing him access to the safety database and teaching him to pull reports as appropriate. These efforts enhanced his ability to actively monitor safety data and meet European regulatory obligations.
Ashfield’s partnership with this client continues to grow. In 2014, Ashfield supported the client in a successful Health Canada inspection. We are playing an integral role with their new senior management to overhaul their worldwide PV processes.
One of the key learnings that Ashfield gained in this relationship is the importance of identifying inefficiencies and proposing solutions in a meaningful and data driven manner. These measures ensure that our client is maximizing their ability to focus on their core business, while we manage tactical the distractions.