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The Challenge 

  • 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).

The Solution 

  • Planet Pharma delivered talent that the client required including a lead data
    manager, database developer, and a data programmer who helped build the EDC system and finalize data transfer specifications for the 10 third-party vendors.
  • Our consultants helped the client quickly identify all variables requiring  capture within the CRF to complete the EDC build. We also provided a biostatistician to evaluate and identify the necessary data points collected from the smartphone applications to create simplified data transfer specifications which were executed and completed on time, prior to the first data transfer.
  • In addition, our consultants assisted in coordinating a test transfer from each of the third-party vendors to ensure specifications were followed and matched the sponsor requirements.

The Results 

We were able to provide the client with the talent they needed 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 client’s manufacturing decisions.

Our data management consultants helped the client complete the EDC build on time for the first patient visit.