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Case Study 1:
NDA Preparation

This mid-tier pharmaceutical company approached Umen & Co. to prepare study reports of Phase 1, 2, and 3 trials, a unique meta analysis report, the ISE, the ISS, and various CTD Module 2 documents. At the time, the client was still enrolling patients in the Phase 3 trials.  Although the volume of work was substantial, the early timing afforded us the opportunity to work with the client's team to prepare for the Pre-NDA meeting and develop a logical and comprehensive submission strategy spanning all of the critical documents.

We began the planning phase of the project by working with the client to hone the draft package insert (PI). Using the PI as a foundation, we then mapped out the various reports, summaries, and overviews. The first step in this process was the compilation of the NDA table of contents. Next, we created "shell documents" which outlined the document structure and specified the overall content and format of the tables, figures, and listings (TFLs). The TFL specifications were then provided to the SAS programmers for implementation. The overall strategy and implementation plan considered not only the relationships within a particular document, but also the relationships among documents. Mapping these interrelationships was a critical strategic element of the submission plan, which later facilitated the process of annotating everything in the PI to Module 2 and to Modules 3, 4, and/or 5.

During implementation, we further coordinated the NDA preparation efforts by involving experts from our extended network including clinical pharmacologists, biostatisticians and SAS programmers, and an electronic submission publisher. As part of finalizing the shells prior to database lock, we wrote boilerplate text that was expected to remain constant regardless of the final data. In parallel, we also reviewed individual patient data by accessing CDISC formatted datasets using various e-review tools. In conjunction with the client's team, we then developed a strategic approach to writing data-driven content based on likely outcome scenarios for the pivotal trials. Further, we linked the programmed TFLs with the document shells to enable real-time data updates. With the help of the client's IT department, we were able to institute a custom process that enabled the writing, programming, editing, and reviewing tasks to be facilitated by a web-enabled, 21 CFR Part 11 compliant document management system.

All of this "up-front" work ultimately enabled our team to complete the documents with considerable efficiency upon database lock. The project culminated in a timely, logical and comprehensive set of NDA documents, with a well-supported PI.

Umen & Co.  The Leader in NDA Preparation Since 1981