Service Description

All the data management activities like building the databases, review the data , create documents for the task , monitoring. hold the TMF etc.

What Went Well

The CRO for able to perform all the task which were contracted out to them and were able to provide very good data qaulity. Therer were very proactive and tried to achive the tasks within th eagreed timelines. There had very weel defined proceeses which helped our compnay during the JNDA audit and had very minimal issues.

What Could Be Improved

Nothing much to say here as they were good inpoerformong their tasks.

Lessons Learned from the Experience

The CRO was able to provide guidence while developing the study whiich were very useful as we were performing the Study in Japan for the1st time. Since it was in Japn, we learnt that there culture is different and sicne they have th etop down approach in decisionmaking we came to know that we need to assign additonal for each task.