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 new rare diseases
Flexible engagement models: full authoring, collaborative drafting, or QC-only support
Fully US-based writing team ensures responsiveness and quality
Frequently Asked Questions
A BLA is the formal submission to the U.S. FDA to request approval for a biologic product. It includes evidence from preclinical, clinical, and manufacturing studies.
BLAs are for biologics, while NDAs are for small-molecule drugs. BLAs place greater emphasis on CMC data due to the complexity of biologic manufacturing.
A BLA includes administrative and summary information as well as full CMC, nonclinical, and clinical data modules, proposed labeling, and risk management plans.
Expert writers ensure data is clear, accurate, and compliant—minimizing FDA questions and avoiding costly delays.
Engaging early in development ensures consistency across all modules, reduces rework, and keeps your submission on track.