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Insight

Ashfield’s client, “Client A”, a large pharmaceutical company who continues to grow through acquisition, purchased “Client B”, another large pharmaceutical company.  This acquisition required 2,500 cases from Client B’s Empirica Trace database be merged into Client A’s version of Argus via E2B plus coding.  This project consisted of data entry, QC and reconciliation.

Idea

Ashfield saw the need for preplanning so they proposed a work ahead strategy beginning 3 months before the Empirica Trace database was set to be closed.  Ashfield quickly hired a data entry team of five (5) people to manually migrate legacy cases into the Argus database.

In addition to the legacy data migration, a Business Continuity Plan was created to support the systematic integration from Client B’s Empirica Trace to Client A’s Argus database.  The Business Continuity Plan detailed what would need to take place if Empirica Trace was closed and new cases needed to be submitted, information needed to be added, etc. The plan stated that follow-up cases due after Empirica Trace close would be processed manually and submitted if due during the planned outage.  These cases would be submitted manually via the FDA manual submission portal.

Throughout the migration Ashfield completed duplicate searches to ensure no information slipped through the cracks.

Ashfield proposed an accelerated timeline for medical review allowing themselves an additional two weeks to troubleshoot anything that may come up before Empirica Trace officially closed. Ashfield prioritized all cases by due date to ensure regulatory compliance and instituted overtime to complete as many cases as possible before migration began in earnest.

On the day Empirica Trace went down, the Ashfield team entered all new cases (serious and non-serious cases) in Argus. Ashfield was able to track follow-up cases manually for entry into Argus post migration.

Because two different databases were involved, the integration required Ashfield Pharmacovigilance to select team members to assist in any urgent processing or migration issues such as case clean up or mapping errors.  Luckily, Ashfield was already the vendor of choice for both companies so the consistency in product knowledge and historical understanding of why and how things were done greatly helped Ashfield navigate the large volume of cases.

Impact

This project resulted in a successful migration with no late cases, and no information lost due to database outages.

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