Clinical Study Report (CSR) Services

Regulatory-Compliant CSRs for Clinical Trial Submissions

A Clinical Study Report (CSR) is a crucial regulatory document that provides a comprehensive, detailed, and structured analysis of clinical trial data, ensuring compliance with ICH E3 guidelines. At Clievi, we specialize in authoring, reviewing, and submitting CSRs tailored to the specific requirements of regulatory agencies such as the FDA, EMA, MHRA, PMDA, and Health Canada. Our CSRs integrate statistical analyses, clinical outcomes, safety data, and efficacy results to support new drug applications (NDAs), biologics license applications (BLAs), and marketing authorization applications (MAAs).

Our Clinical Study Report (CSR) Services

1. Full Clinical Study Report (CSR) Development

ICH E3-Compliant Structure: We develop CSRs adhering to the International Council for Harmonisation (ICH) E3 guidelines, ensuring consistency, clarity, and regulatory acceptance.
Phase I-IV CSR Writing: Expertise in CSRs for early-phase (first-in-human) to late-phase (pivotal) trials, covering safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).
Narrative Writing for Adverse Events (AEs): Crafting concise, medically accurate narratives for serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
Statistical Results Interpretation: Integrating Kaplan-Meier curves, Cox regression models, logistic regression, and other biostatistical methodologies to present meaningful conclusions.

2. Regulatory Submission-Ready CSRs

New Drug Applications (NDAs) & Biologics License Applications (BLAs): Creating FDA, EMA, MHRA, PMDA, and TGA-compliant CSRs for drug and biologic submissions.
Common Technical Document (CTD) Module 5 Compliance: Structuring CSRs to fit within the Clinical Study Reports section of Module 5 of the eCTD format for seamless regulatory filing.
Paediatric Investigation Plan (PIP) & Orphan Drug Applications: Specializing in CSRs for pediatric trials and orphan drug designations.
Real-World Evidence (RWE) CSR Preparation: Supporting post-marketing surveillance (PMS) studies, Phase IV trials, and pharmacovigilance reporting.

3. Biostatistical Analysis and Data Interpretation

Tables, Listings, and Figures (TLFs): Generating statistical outputs, including forest plots, waterfall plots, and Kaplan-Meier survival curves.
Subgroup Analysis & Sensitivity Testing: Conducting stratified analyses to identify patient population variations and confirm data robustness.
Descriptive & Inferential Statistics: Applying ANOVA, t-tests, chi-square tests, and mixed-effects models for thorough statistical assessment.

4. Patient Safety & Pharmacovigilance Reporting

Integrated Summary of Safety (ISS) & Integrated Summary of Efficacy (ISE): Compiling multi-trial safety and efficacy data into regulatory-compliant reports.
Risk-Benefit Analysis for Regulatory Decision-Making: Evaluating risk mitigation strategies and benefit-to-risk ratios for market approval.
Serious Adverse Event (SAE) Narratives: Developing detailed reports of individual case safety reports (ICSRs) and pharmacovigilance databases.
Post-Marketing Safety Surveillance (PMSS) Reports: Supporting PSURs (Periodic Safety Update Reports) and DSURs (Development Safety Update Reports).

5. CSR Peer Review & Compliance Checks

Regulatory Gap Analysis: Reviewing CSRs for consistency with study protocols, SAPs (Statistical Analysis Plans), and regulatory guidelines.
Medical and Statistical Peer Review: Ensuring scientific accuracy, clarity, and logical flow for regulatory compliance.
Quality Control (QC) & Document Formatting: Ensuring CSRs adhere to GxP, Good Clinical Practice (GCP), and ISO 14155 standards.

Why Choose Clievi for Clinical Study Reports?

Regulatory Expertise: Proven experience in FDA, EMA, MHRA, Health Canada, PMDA, and WHO guidelines.
End-to-End Support: From protocol synopsis to final CSR submission, we cover every aspect of clinical trial documentation.
Data-Driven & Evidence-Based Approach: Using real-world evidence, meta-analyses, and advanced biostatistics to support study conclusions.
Multi-Disciplinary Team: A dedicated team of medical writers, statisticians, regulatory experts, and pharmacovigilance specialists.

Get Started with Clievi’s CSR Services

Ensure regulatory compliance, scientific accuracy, and data integrity with Clievi’s Clinical Study Report (CSR) services. Contact us today to discuss your CSR requirements for clinical trial submissions.