Integrated Data Package and Summaries of Safety and Efficacy for Small Pharma

Background

In 2018 we at CROS NT supported a small pharmaceutical company with a complicated Integrated Data Package and Summaries of Safety and Efficacy that was required for an FDA submission. This challenging data harmonisation project our client requested involved multiple studies in various phases from I to III.

Challenge

Our experienced teams are used to dealing with data in different formats and stages of development and this project was a perfect example of this. The studies requiring harmonisation were at varying stages of development where there was a combination of:

  • Database raw data
  • CDISC SDTM or ADaM
  • CDISC-like SDTM+ or ADaM+ data
  • Legacy datasets

In this project, we were facing several challenges:

  • It can be a very time-consuming effort that is required for the collation of all data sources to ensure that full traceability is maintained across studies
  • To harmonise so many different data sources the programming team must be extremely familiar and comfortable with the many versions of CDISC and the latest updates available to be able to quickly recognise inconsistencies in the data
  • Beyond the data harmonisation effort, there was also the task of ensuring that the final outputs were consistent with the individual CSR results.

Our Solution

At CROS NT we specialise in ISS/ISE data integration studies and our solution was to first identify the most appropriate team members who are CDISC experts, had data pooling and prior FDA submission experience. This step was imperative in ensuring as smooth a conversion as possible with multiple data formats and sources.

Our next steps included:

  • Performing a GAP analysis to determine the current state of the data and the effort required to get to submission-ready CDISC compliance
  • Creating an integrated ADaM specification that would be the basis for the submission and the strategy for the pooled data taking care to include enough detail to ensure the programming team could complete the tasks efficiently
  • Perfoming a full QC check on the final outputs for the ISS/ISE versus the CSR of the individual studies to ensure full consistency with the base studies
  • Performing a full gap analysis allowed us to identify the areas of effort and devise an appropriate strategy to deliver this submission successfully.