Title : DATA VALIDATION

Client Situation

A top-5 global pharmaceutical company, like many of its peer companies, had outsourced all of its data management operations to a large BPO (Business Process Outsourcing organization) that delivered these services in a globally cost-optimized model. They had retained the programming responsibility in-house, wherein programmers were mostly in-sourced contractors who were managed by a few senior in-house programmers. The Client's programmers consistently found that data discrepancies and data errors were being flagged while reviewing the draft TLGs (tables, listings, graphs). They realized that the data management team used by the vendor didn't have much experience in global clinical trials and didn't have the depth of understanding of clinical trial data that is required to catch such data errors in the course of the basic discrepancy management activity. However, since the data management function was completely outsourced, they didn't have in-house resources that could train, coach and mentor the DM provider's resources to bring them up to the required level.