How to Deliver Module 2 of an NDA in 12 Weeks

Strategic Planning for Accelerated NDA Module 2 Delivery

Imagine you’re tasked with writing a Phase 3 Clinical Study Report (CSR), along with several Common Technical Document (CTD) Modules, all within a tight 12-week deadline – where do you start?

This guide is here to help you navigate the challenges of planning strategically for such a demanding project. Whether you're facing a similar situation or tackling multiple documents under time constraints, we've got the insights to help you succeed.

The Scenario

Let's illustrate our 'client' (a hypothetical example):

The client:

A European biotechnology company developing therapies for Hepatocellular Carcinoma (HCC)

Their problem:

They need help preparing for a New Drug Application (NDA) submission to the FDA. They're in a Phase 3 trial and plan to submit once the data is ready.

Project Scope and Challenges

The project’s scope includes a comprehensive Phase 3 CSR and CTD Modules 2.7.3 (Clinical Efficacy), 2.7.4 (Clinical Safety), and 2.5 (Clinical Overview), as well as an Assessment Aid to be submitted to the FDA.
Multiple medical writers will need to be assigned to this project, given the scope and the tight submission deadline of 12 weeks. Assigning multiple writers to work in parallel allows for faster completion but requires careful coordination to maintain consistency across various modules.
The medical writing team must be carefully selected based on their expertise relevant to the project. Medical writers assigned to this project should have the following:

HCC expertise

Experience developing a Phase 3 CSR, an NDA, and CTD Modules

Experience with FDA submissions

Key Success Factors

When facing tight deadlines, achieving project success relies on careful and proactive planning. It is important to consider several critical factors when preparing for a project of this scale.

1) Working in parallel

Assign a team of multiple writers to work in parallel on related sections of the CSR and CTD Module 2.

Here's an example of how to do so:

Writers should work on sections of the CSR and CTD modules that correlate with each other to increase efficiency and consistency.
Align draft and review times to ensure the client does not have too much to review at once and that work can continue consistently while other drafts are being reviewed.

2) Strategic planning and order of documents

Stagger the start times of documents that rely on the CSR. For example, don’t start Module 2.7.3 and 2.7.4 until the first draft of the CSR has been reviewed and comments have been made. This saves time undoing/rewording the same sections in multiple documents.
The dedicated project management team and client team work together to map out key dates for all drafts, reviews, meetings, and finalization before work commences.

3) Efficient strategic meetings and feedback

Streamline feedback by aligning CRMs so that overall progress can be discussed in a single meeting, and the next drafts/reviews can all begin in line with timelines.
All key project team members and medical writers attend and discuss feedback, comments, and next steps. This keeps everyone on the same page and avoids repetition.