Planning for a Successful Safety Data Conversion

Abstract

Proper planning is critical when converting or migrating adverse event databases, especially when products are shifted between different companies. This article, based upon experience gained in several recent conversions, presents key elements that must be addressed when preparing for safety database conversions. Initial planning should include a careful definition of project scope, based on both business process reviews and technical analysis of the database systems. Throughout the project, sufficient resources, drawn from all groups that are impacted by the conversion, must be committed to the conversion effort to be sure all issues are identified and resolved. Communications must be open and frequent, not only among the conversion team but also with other affected groups. Contingency plans must be prepared in case of delays or problems in the conversion, and provision must be made for follow-up support after the conversion.