CTD Module 2 Writing | Clinical Overview & Summary

Module 2 of the Common Technical Document contains the summaries that health authority reviewers read first. These documents frame the narrative for your entire submission. A well-crafted Module 2 guides reviewers through your development program, highlights key efficacy and safety findings, and builds the case for your product's benefit-risk profile.

ESW Communications develops Module 2 documents that synthesize complex clinical and nonclinical data into clear, compelling summaries. We work with your regulatory strategy to ensure these critical documents support your overall submission goals.

Module 2 Documents We Develop

Module 2.5: Clinical Overview

The clinical overview provides a critical analysis of your clinical development program. We develop overviews that present the rationale for your development approach, summarize key efficacy and safety findings across studies, discuss the benefit-risk balance, and address anticipated reviewer questions.

Module 2.7: Clinical Summary

The clinical summary compiles detailed summaries of biopharmaceutics, clinical pharmacology, efficacy, and safety. We develop each subsection to present your data systematically across all required components.

Module 2.4: Nonclinical Overview

The nonclinical overview interprets your pharmacology, pharmacokinetics, and toxicology findings in the context of intended clinical use. We highlight findings relevant to human safety.

Module 2.3: Quality Overall Summary

Working with your CMC team, we develop quality summaries that present drug substance and drug product information clearly with alignment across modules.

Module 2.7 Subsections

2.7.1: Summary of Biopharmaceutic Studies and Associated Analytical Methods
2.7.2: Summary of Clinical Pharmacology Studies
2.7.3: Summary of Clinical Efficacy
2.7.4: Summary of Clinical Safety
2.7.5: Literature References
2.7.6: Synopses of Individual Studies

Our Module 2 Development Process

1. Strategic Alignment

We review your regulatory strategy and key messages to ensure Module 2 documents support your overall submission goals.

2. Data Compilation

We work with completed CSRs, integrated summaries, and source data to compile comprehensive summaries.

3. Cross-functional Coordination

We coordinate with clinical, nonclinical, CMC, and regulatory teams to ensure consistency across modules.

4. Expert Review

Internal medical and regulatory review ensures accuracy and strategic alignment before client delivery.

Frequently Asked Questions

When should Module 2 development begin?

Module 2 development typically begins 4-6 months before submission, once pivotal study data are available. However, planning and shell development can start earlier. Early engagement ensures Module 2 documents are aligned with your overall submission strategy.

How do you handle evolving data?

We build flexibility into our process. As additional data become available or analyses are refined, we incorporate updates efficiently. Our document management approach ensures version control and traceability throughout development.

How do you ensure consistency across Module 2 documents?

We develop Module 2 documents as an integrated package, with consistent messaging and cross-references across 2.3, 2.4, 2.5, and 2.7. A single lead writer typically oversees all clinical Module 2 documents to ensure alignment.

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CTD Module 2 Writing Services