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Insight:

Our post market pharmacovigilance (PV) client was planning a clinical trial, which was being executed by a large clinical CRO. Our client was deciding whether to bundle PV into the CRO’s clinical trial package, which would have provided a cost savings.
The client had employed this particular CRO for pharmacovigilance in the past and was unhappy with the product they received. They dealt with many quality issues and found that things were falling through the cracks. Much of this stemmed from their siloed structure and lack of consistency in how cases were processed. The client did not have a single point of contact and had to jump through hoops to reach the appropriate project manager all of whom were located across multiple time zones. Moreover, they found that case processing was being outsourced to multiple places. The client was US based, yet cases were being processed in New Jersey, Wilmington, NC, and Raleigh, NC, with the majority of cases being processed in India. Additionally, regulatory reports were submitted from the offices in Ireland.
These frustrations contributed to the client moving their post market pharmacovigilance to Ashfield pharmacovigilance. However, clinical trials are costly and price savings were very enticing.

Idea:

Ashfield pharmacovigilance offered a high touch connection using a cohesive, dedicated team who already had a comfortable relationship with the client. Ashfield PV was transparent in identifying who would be processing their data and confirmed that all PV activities would be completed in our RTP office.
Ashfield PV proposed a single safety database containing all clinical trial serious adverse event (AE) data. The client was offered full access to the database to review individual cases and to pull aggregate data as needed. Ashfield pharmacovigilance and the client partnered to develop data entry and coding conventions, providing consistency across all studies. When the product was approved, post-market AEs were added to the database, providing the client access to a complete safety dataset across the life of the product. Further, the client recognized that processing clinical AEs in the same database as post-marketing events would save the high cost of moving the clinical trial data to the post-marketing database at the time of market launch and mitigating regulatory risks associated with data migration.

Impact:

The client’s head of PV liked the attention his company received from Ashfield pharmacovigilance, that he was provided a single point of contact and that he could easily reach his Program Director. He noted that the service and quality were superior to that received from the other CRO. All data is now housed in single storage site. The client is enjoying the substantial value that comes from a dedicated team working with a product throughout its lifecycle. Pharmacovigilance is too critical an activity to allow cost to be the sole decision maker when choosing a service provider.

Reflecting our values:

Ashfield PV’s commitment to quality was the ultimate deciding factor when our client chose to have us handle their clinical PV. Ashfield Pharmacovigilance ’s knowledgeable staff provided a level of expertise unmatched by that of a large CRO.

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