ICH E3-compliant CSRs that support your regulatory submissions
The clinical study report is the cornerstone of your regulatory submission. A well-written CSR presents your clinical data clearly, accurately, and in full compliance with ICH E3 guidelines. At ESW Communications, we develop comprehensive clinical study reports that meet the expectations of global health authorities and position your product for regulatory success.
Our medical writers have extensive experience across therapeutic areas and study designs. We understand the nuances of presenting efficacy and safety data in ways that tell a compelling scientific story while maintaining strict adherence to regulatory requirements.
Complete clinical study report writing from protocol finalization through final report. We work closely with your clinical, biostatistics, and regulatory teams to develop a CSR that accurately presents your study results.
For supportive studies, bioequivalence trials, and other studies where a full CSR may not be required, we develop streamlined abbreviated reports that meet regulatory requirements.
When study data requires updates or health authorities request additional analyses, we develop CSR amendments that seamlessly integrate new information while maintaining document integrity.
For historical studies that require retrospective documentation, we develop legacy CSRs that reconstruct the clinical narrative from available data to meet current regulatory standards.
We review the protocol, statistical analysis plan, and available data to develop a detailed CSR shell and writing plan.
We create a comprehensive document shell with all required sections, tables, figures, and appendix placeholders aligned with ICH E3.
Our writers integrate statistical outputs and develop clear, scientifically accurate narratives for each section.
Internal medical and editorial review ensures accuracy, consistency, and compliance before client delivery.
We manage comment resolution and revisions through final approval, ensuring timely delivery.
Timeline depends on study complexity and data availability. A typical Phase III CSR requires 12-16 weeks from statistical output availability to final report. Phase I studies and abbreviated CSRs can often be completed in 8-10 weeks. We develop detailed timelines during project kickoff.
We need the final protocol and amendments, statistical analysis plan, clinical study report shell or template (if available), statistical outputs (tables, figures, listings), and access to your clinical and biostatistics teams for clarification questions.
Our CSR shells are built on ICH E3 structure with all required sections and content elements. We maintain detailed checklists to verify compliance, and our QC process includes verification against current guidance documents.
Contact us to learn how ESW Communications can support your clinical study report needs.
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