Service Description

The cro was contracted to perform all data management functions. These included report generation, query resolution, data review and transfers.

What Went Well

All aspects of data management went well. The CRO attended all clinical site team meetings and all data management meetings. Creation and generation of data review. SAE reconciliation and all status reports were good.

What Could Be Improved

I have to consistently pull out the document that assures me of what data cleaning is being performed. If a data point should be cleaned it MUST be in the plan. Total data management review to me means running ad hoc reports without assuring it is in the document.

Lessons Learned from the Experience

The CRO thinks out of the box, they are very supportive when issues are brought up. INC is willing to bring up the hard issues (Personality issues) and directly try to find a way to reduce the concern. The have been generating reports that were detailed out in the Clinical plan, but no one in clinical was willing to review these documents they took it upon them selves to start review of these documents instead of just constantly pushing for clinical review.