MAA ISS Analysis Data Package
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.
A marketing authorization application (MAA) is a major milestone in the development of a product. When working toward such an important event, having a trusted partner who can step in quickly and help prioritize and produce submission-ready deliverables can be the difference between meeting the submission deadline and being forced to delay the submission.
Practical knowledge of regulatory data requirements as well as supporting programming and biostatistics methodologies is essential for success.
This case study highlights a common scenario that requires practical expertise as well as a deep understanding of the client’s challenges. The TradeCraft team developed and implemented a medical review process and rolling delivery of data that supported the client’s tight timeline. These sophisticated strategies were only possible because TradeCraft was able to rely upon their own advanced knowledge and expertise to drive their recommendations and efforts. They produced the compliant analysis data sets so the client could meet their submission goal.