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 Changes in the database. All of these situations may be associated with Safety Data migration.

Safety data migration is inevitable in the following situations:

1. Merger and Acquisitions

2. Setting up a Pharmacovigilance System

3. Change in Database

4. Database upgrade

Although numerous vendors or service providers have expertise in this area, pharma companies (especially the large or aggressively growing ones) may even consider having in-house expertise or a combination of in-house and external support.

One should remember that this is one of the favourite areas for auditors and inspectors.

Why are inspectors interested in evaluating safety data migration projects?

1. Adequate Documentation

2. CSV Approach

3. Availability of ICSR Source Documents

4. Completeness of migrated safety data

5. Project management plan and agreement/ contract

6. Audit Trail Availability

Types of Safety Data Migration

1. Manual Entry and processing

2. Migration from Excel

3. E2B-XMLs

4. Data Dump (Programmatic migrations)

5. Combination (Hybrid) Methods

Challenges in Safety Data Migration

1. Incomplete migration

2. Non-availability of source documents

3. Incomplete documentation

4. Approach related issues

5. Issues with Audit Trail

6. Incomplete data in PSURs

7. Missed Expedited Reports and Duplicate Reports

A safety data migration project increases the chance of having an inspection by multi-fold.

Thanks to the well-formulated intelligence system and media that help the inspectorate offices keep track of mergers or acquisitions. Not to forget, this may even be one of the reasons for a triggered inspection.