Clinical Data Sciences

An east coast based midsized pharmaceutical client required immediate data management services to take over EDC build and the creation of data transfer specifications for 10 third party vendors (Central Lab, PK, and several smartphone applications).

Key Challenges

  • Tight timelines for database go-live  
  • Complicated (non-CDISC) format of third-party smartphone application data
  • Large amount of data (some smartphone applications collected data continuously resulting in tens of thousands of records per subject)

Treximo Solution

Treximo deployed a data management team consisting of a lead data manager, database developer, and a data programmer to build the EDC system and finalize data transfer specifications for the 10 third-party vendors. The Treximo data management team quickly read the study protocol and identified all variables requiring capture within the CRF to complete the EDC build. The Treximo data management team identified the benefit of bringing in a Treximo biostatistician to evaluate and identify the necessary data points collected from the smartphone applications which allowed the data manager and data programmer to create simplified data transfer specifications which were executed and completed on time prior to first data transfer. In addition, Treximo data management was able to coordinate a test transfer from each of the third-party vendors to ensure the data transfer specifications were followed and the data received matched the sponsor requirements.

Outcome

  • Treximo data management team was able to complete the EDC build on time for first patient first visit.
  • Able to create, test and implement third party transfer specifications prior to first transfer of data allowing for an on time and accurate interim analysis which was crucial for the clients’ manufacturing decisions.