migration

In recent times, the pharmaceutical industry has been witnessing quite a few Mergers and Acquisitions (M&A) as companies want to grow organically as well as inorganically. Indeed there is intense competition in this field and companies want to sustain competition, and want to remain ahead of their peers. Considering the growing regulatory expectations, companies need […]

Safety Data Migration can be undertaken using the following methods: 1. Manual Entry and processing: Simplest, cost-effective, and suitable for small datasets (~100 ICSRs). The ICSRs are manually entered into the new system; source documents are attached. 2. Migration from Excel: The ICSR data is extracted from the spreadsheet database and migrated into the safety […]

Gone are the days when companies used to have complete access to all source documents (electronic and non-electronic), following any kind of M&A. One need not get surprised if the migrated data does not have even basic information such as the name of the patient. It is quite logical that one may get concerned if […]

It may be prudent to state that a Pharmacovigilance professional may have experienced or participated in at least one Safety data migration project in his/ her lifetime, directly or indirectly. Scaling up of Pharmacovigilance Systems is generally associated with the up-gradation of the Safety database, infrastructure updates (? change from on-premise to Cloud) or even […]