Big Pharma
Situation: VeryPharma is a big pharma company, with many products and many therapy areas spread across several geographically distant sites.
It has been quite successful, but recently learned that it is very slow in comparison to industry metrics.
Its management decides that it needs to eliminate the cross-therapy differences in data structures to allow the shared database programming department to operate more efficiently.
It also realizes that it have increased liability with respect to safety issues because safety data are handled differently at different sites, and it is also not able to pool it data to search for subtle safety signals.
It does have lots of examples of protocol and CSR templates, databases and CRFs, monitoring guidelines and edit checks, but they are all slightly different. .
Implementation: Kestrel brings in the DLP tools, including the DLP template, creator instructions, and process definitions, and helps VeryPharma to take their existing materials and harmonize them in the DLP framework.