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Data Migration Approach for Handling Legacy Safety Data -Pharmacovigilance

06 Mar 2018

Pharmaceutical industry, in today’s world, is expanding with an immense business potential; with a steady growth in developed markets but rapidly growing in the emerging markets. Pharmaceutical companies are moving towards mergers and acquisitions (M&A) for potential business expansion and global reach in various geographies, by either acquiring companies, or increasing revenues by acquiring blockbuster products, or merging with regional companies to increase product reach in terms of its therapeutic expansion or its sales. With extensive increase in the number of products being launched into the global market, there is also a substantial increase in the number of adverse events or other safety concerns associated with these products. Hence, necessitating reporting and tracking these adverse events has led to the growth of Pharmacovigilance market share.

Pharmacovigilance aims for the early detection of an adverse event and/or safety issues, assessing its causality against the marketed drug, planning necessary preventive methods, and timely reporting to the regulatory authorities. Information received from various sources is scrutinized and recorded into the safety database to create a valid individual case safety report (ICSR), and then it is further processed and submitted to regulatory authority/ies. Safety data handling and management is an integral part in pharmacovigilance, which also encompasses legacy data. With M&A happening across the Pharma industry, the need arises for managing a product’s legacy safety data. Sometimes, due to the large amount of data that needs to be transferred from one company to another, data migration activity becomes a challenge based approach with many iterative phases that need to be channelized in ‘one sync’ for the best result. Data migration approach includes the migration plan that defines the overall do’s and don’ts of the activity. The migration plan should be drafted in-line covering all the aspects required for the legacy data migration from the existing system (may be the safety database) to a newer safety database, or migration of the legacy data into the existing system.


Challenges and Risks Associated with Safety Data Migration

The challenges or issues, which sometimes may lead to migration failure, may depend on some of the following parameters:

  • Inappropriate data migration planning
  • Lack of system knowledge or functions
  • Wrong interpretation of business rules or logic applied in the safety database architecture
  • Improper data structure designing
  • Data mapping across both the systems
  • Technical aspects related to field character limits and type, which vary from system to system
  • Inconsistent or inaccurate data availability
  • Handling of duplicate or follow up records
  • Lack of standardization across systems and processes
  • Iterative data cleaning process
  • Handling of the source documents and other related documents
  • Inadequate data checking and validation – randomization of data check and the validation approach that needs to be adapted, prior to production
  • Reconciliation of entire migration activity
  • Costing of entire migration activity


Data Migration Approach

Data Migration approach may vary from case to case depending on the methodology used as mentioned below:

  • Direct database to database migration – Direct meta data transfer using db scripts
  • Fully-automated database migration – Using automated data loaders executing the migration activity (automated E2B and non E2B field mapping through data loaders)
  • Semi-Automated database migration – Partial activities require manual intervention (Uploading E2B data (XML) files and executing non E2B data manually)
  • Manual database migration –By manually re-entering 100% case details from existing system to the potential system

The following aspects should be considered while analyzing and planning the legacy data migration activity:

  • For Analysis – Planning Phase
  • Quantum 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


  • Migration steps along with system validation – Execution Phase
  • User Requirement specification – in detail
  • Preparing data dictionary and data elements for easier understanding
  • Migration scripts generation
  • Test data migration on any virtual set up – to check its acceptance
  • Validation of the potential safety database – includes entire validation documents
    • Validation plan
    • Functional specification against user requirements
    • Risk or impact assessment
    • IQ-OQ-PQ protocol
    • IQ scripts (as applicable)
    • OQ scripts (as applicable)
    • PQ scripts (as applicable)
    • User acceptance for validation
    • Traceability matrix (explaining relation between URS – PQ scripts)
    • IQ-OQ-PQ Summary Reports
    • Validation summary report
  • On Production – legacy data load and user check for its correctness and compliance
  • Summary report – summarizing the above mentioned activities
  • Production database for use


Lambda has vast expertise and an experienced team to handle the legacy data migration for its clients across geographies. Well-established and in-depth procedures, work instructions and guidance’s listed with end to end activity of handling the legacy data transfer from various safety databases (Argus, ArisG, AERS etc.) into its in-house global safety database PvNET. Lambda has a predefined checklist to ensure that the relevant and appropriate data which need to be migrated are captured accurately. Lambda’s PV Team (having functional SME’s) can quickly accommodate and plan the data migration activity with their analysis, and systems’ and functional skills. Lambda till date has performed the data migration for approximately 20,000+ cases seamlessly for their various clients using different data migration approaches mentioned above. Lambda provides end to end PV solutions & services @ the one stop shop.

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