BIOSTATS AND CLINICAL PROGRAMMING CASE STUDIES
CDISC SEND Compliant Data for FDA Submission
The CDISC Standard for the Exchange of NonClinical Data (SEND) is required by the FDA for the submission of nonclinical (animal) data. This case study illustrates how TradeCraft helped a client meet a strict submission deadline by producing CDISC SEND compliant data deliverables.
For teams who are preparing for a major regulatory submission, the CDISC requirements for the data components of the submission can be quite overwhelming. Producing compliant output can be challenging when dealing with legacy studies as well as ongoing trials. Tight timelines often add pressure on teams that are already working at capacity.
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.
Data Support for Conference Poster
Presenting relevant research data at a conference can help to communicate a sponsor's most recent findings and share the information with broader audiences. However, it can be challenging to present the data in a digestible way that is concise, yet detailed enough for audiences to understand your message.