Title : Study quality monitoring

Client Situation

A top-20 global pharmaceutical company evaluated all its Biometrics processes, including a root-cause analysis of the inadequacy of data/subjects available for certain types of efficacy analyses. They found that missing or invalid data identified after study completion led to inadequate data being available for certain key analyses, like the evaluable subset analysis for primary efficacy. The Client desired to put in place a plan and a process for monitoring the quality of the study on an ongoing basis, over and above monitoring of the quality of data. This was discussed with Sciformix.