Managing Pharmacovigilance Data Migration

The successful pharmacovigilance safety data migration requires a strategic and structured approach. Aspects such as data integrity, quality, security and regulatory compliance must be thoroughly considered. Therefore, the planning of safety database migration to another system can sometimes become daunting and stressful task. In this blog entry, we will attempt to shortly describe the options and common challenges encountered during the pharmacovigilance data migration process.

To begin with, an organization should first decide on data migration method. The decision will mostly depend on the number of cases and the complexity (due to the difference between the configurations of target and legacy system). This can be a manual migration (when all PV cases/data are re-entered from the source system to the target system manually) or an automated migration. During a fully automated migration, the additional non E2B custom fields are mapped prior to the migration so that they could be imported to the new system along with the E2B data. However, a fully automated migration shall require significant IT support to carry out the field mapping and assure that the import is done correctly. Many organizations may also choose a mixed or semi-automated methods, when both manual and automated migration techniques are employed. For example, during a semi-automated migration, the standard E2B data are migrated automatically and non-E2B custom fields are re-entered from the source system to the target system manually.

Furthermore, before the data migration may begin, a Data Migration Plan should be developed. It should include a thorough strategy of the migration project and the main rules for data migration. The procedure must consist of clear guidance to mitigate interruptions and to achieve compliance. During its development process, it is crucial to evaluate different approaches, products or number of cases that will be needed to migrate. The following aspects should be considered while analyzing and planning the legacy data migration:

• Quantity of legacy data that needs to be migrated
• Existing system functionality or business functions
• Existing system data structure or configuration analysis
• Data extraction methods from existing system
• Acceptable data format by potential system
• Potential system’s functionality
• Potential system’s data structure and its configuration set up

Data migration procedure must strictly follow the developed Data Migration Plan and consist of clear steps in order to mitigate interruptions, safeguard data integrity/quality/security and achieve compliance. Regardless of the migration approach selected (automated ETL tool, XML import, re-entry), the new target database must be fully set-up and data migration must be included in a validation exercise.

Executing the data migration should be pretty straightforward if you have created a thorough and well-thought-out Data Migration Plan. Still, you will very likely encounter a surprise or two along the way. The common pitfalls and challenges that are faced during the data migration process and that should be under your radar from initial planning till the end are:

• Inadequate planning itself and insufficient data migration plan
• Limited knowledge of the safety database and it’s functionality
• Misinterpreted business rules within safety database
• Technicality related to types and limits of input characterization
• Inconsistent available data
• Follow-up or duplicates management
• Data cleaning process
• Case related documentation (source data, correspondence, etc.)

If you are considering a data migration, Insuvia’s experienced team can strategically guide you through the entire process. At Insuvia we specialize in pharmacovigilance and clinical safety management services. Pharmacovigilance data migration in one of the Insuvia services offered for pharmaceutical companies. We are fully capable to ensure full spectrum PV support starting with data migration plan preparation until final case entry and further database maintenance.