Phase III Submission Rescue

Sponsor teams routinely find themselves in difficult situations when they receive clinical data from their contract research organizations (CROs) that is not submission-ready. The data is often received late in the process, leaving little or no time for the team to identify, assess, and correct the issues. Depending on the issues, the output may require minimal rework or extensive reprogramming. 

Regardless of the tight timelines, compliance and accuracy cannot be sacrificed for speed. Producing non-compliant output quickly only adds cost and rework time to a project.

 

This case study illustrates how TradeCraft typically works with clients to understand their submission goals as well as the status of their data. This bigger picture view of the data's current state in the context of their submission goals helps us prioritize efforts and make meaningful recommendations to our clients. 

We target our efforts toward meeting submission goals in the quickest way possible - by producing and delivering submission-ready data deliverables on time, every time. 

TCR offers clinical programming services that help teams prepare for regulatory submissions.

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