Vault eTMF & Study Startup Data Migration

Background Information

A Global Pharmaceutical company hosted study startup (SSU) data in goBalto and Trial Master File (TMF) documentation in a legacy document management system, FirstDoc. The company wished to consolidate this data into their Clinical Vault platform.

Key Problem

The company maintained multiple systems and spreadsheets to manage and track their TMF documentation. A health authority audit highlighted this lack of control around their essential trial documents.

Daelight’s Solution

Working with the business and IT departments, Daelight’s team helped develop and execute a plan to migrate content from the two legacy systems into one, Clinical Vault.

Where applicable, the TMF content was associated to its SSU data. This relationship of TMF documentation to startup data was not possible from within the two legacy systems. Daelight’s analysts worked with the company to identify migration mapping rules in order to minimize enrichment activities and business disruption while maintaining data integrity and compliance.

Results

At the end of the project, Daelight helped the company migrate over 400,000 documents following a “big bang” approach to minimize overhead, decommission an unsupported system and meet the project timelines.