Our client was frustrated by not having real-time access to their safety data in a single database. If the client wanted to evaluate safety data from multiple completed and ongoing clinical trials, reports had to be pulled from each completed study dataset, and the CROs conducting the ongoing trials had to send a report from their respective databases. The client then had to manually merge all of their data. In addition to the logistical challenges, data processing and coding conventions varied across multiple vendors, resulting in inconsistencies in the data.
Ashfield Pharmacovigilance proposed a single safety database containing all clinical trial serious adverse event (AE) data processed by a single entity. The client was offered full access to the database to review individual cases and also pull aggregate data, as needed. Ashfield Pharmacovigilance and the client partnered to develop data entry and coding conventions, providing consistency across all studies; therefore, when the product was approved for marketing, post-market AEs were added to the database, providing the client access to a complete safety dataset across the life of the product.
As a result of the consolidated safety data set and the consistently applied processing and coding conventions, the client noted increased internal efficiency for the medical and scientific staff. Utilizing a single database eliminated the need for multiple licenses and access fees; therefore, the client received a significant cost savings and the product now has a more complete and accurate safety profile, which is critical for regulatory reporting requirements.
Reflecting our values:
Ashfield Pharmacovigilance’s commitment to quality allowed the client to create a cost-effective and efficient process, while building a long-term partnership.