Clinical Study Report (CSR) Writing & Regulatory Support

GLOBAL provides comprehensive CSR authoring and regulatory consulting services for pharmaceutical, biotech, and medical device companies.

End-to-End CSR Writing for Regulatory Submissions

CSRs are critical regulatory documents that present the methodology, results, and analyses of clinical trials in a clear, comprehensive, and compliant format. Whether for FDA, EMA, or global submissions under ICH E3 guidelines, GLOBAL delivers CSRs that meet the highest standards of scientific and regulatory rigor. 

Strategic CSR Services Tailored to Your Study and Region

At GLOBAL, we help sponsors prepare submission-ready CSRs that align with their broader regulatory strategy. From pivotal trials to early-phase studies, our medical writers and regulatory experts craft CSRs that withstand agency scrutiny while clearly communicating the study’s outcomes. We can help you:

• Author ICH E3-compliant CSRs for Phase I–IV studies
• Perform quality control (QC) review of CSRs for accuracy and consistency
• Manage timelines and collaborate closely with clinical, biostatistics, and regulatory teams
• Prepare redacted and lay summary versions for public disclosure
• Align CSRs with CTD Module 5 requirements and global regulatory expectations

Milestones from the Past 18 Months

Our CSR Services Include:

Full-Service CSR Authoring

• Developing CSRs for clinical trials across all phases and therapeutic areas
• Integrating narratives, listings, and statistical outputs
• Conducting consistency checks across clinical sections of the CTD
• Customizing templates to align with sponsor and agency expectations

Redaction & Public Disclosure Support

• Developing redacted CSRs in compliance with EMA Policy 0070 and Health Canada requirements
• Preparing lay summaries for clinical trials
• Verifying anonymization techniques and traceability

Quality Control and Compliance Reviews

• Performing ICH E3 and regional regulatory conformance checks
• Conducting independent peer reviews and cross-functional QC
• Checking consistency against protocols, statistical analysis plans
      (SAPs), and clinical datasets

Modular CSR Contributions

• Writing clinical narratives (individual or pooled)
• Authoring safety sections (e.g., adverse events, exposure, deaths)
• Summarizing statistitcal methodology and efficacy analyses

Why Choose GLOBAL for your CSR Needs?

Experts in ICH E3 and global CSR expectations

Deep understanding of FDA, EMA, and Health Canada preferences

Proven success writing CSRs for oncology, neurology, cardiology, and rare diseases

Flexible engagement models: full authoring, collaborative drafting, or QC-only support

Fully US-based writing team ensures responsiveness and quality

Expert CSR Writing Across All Therapeutic Areas

Whether you’re preparing for your first IND, an NDA/MAA submission, or a regional regulatory filing, GLOBAL is your partner for high-quality CSR development.

Let’s ensure your clinical results speak for themselves—clearly, credibly, and compliantly.