In this project Saber Informatics was engaged by the Client (a large pharma) to help with the tracking of clinical trial supplies. Each clinical research site that participates in an ongoing trial receives shipments of investigational products (IMPs) from the trial sponsor (our Client). IMP containers, whether empty or with any unused product, must be destroyed onsite or returned to the trial sponsor as required by federal and state regulations.
A large pharma typically runs trials that require the participation of a substantial number of sites simultaneously. There are surprisingly large numbers of IMP containers being turned around on a daily basis between company warehouses and trial sites. Each container bears its own ID number that is linked to centrally recorded metadata such as shipped out, destroyed onsite, returned but not yet destroyed by sponsor, etc.
Business rules captured and converted to an automated algorithm.
In an ideal world there would be a perfect record for each container ID: sent out and eventually destroyed. In reality however, sites sometimes do make mistakes and record an incorrect event date, container ID, or omit a record altogether. Such mistakes must be found and corrected (by verifying the data directly with the site).
Working collaboratively with the Client's clinical operations team, Saber Informatics implemented a secure web application (hosted on in-house servers) that runs each Excel file through a documented set of data validation checks designed to flag any data inconsistencies. We were surprised by the immediate positive impact this had on data quality and staff productivity, resulting in significant, measurable savings for the Client.
