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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.
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