DSUR Reporting: Complete Guide to Development Safety Update Reports

A Development Safety Update Report (DSUR) is an annual safety report submitted to regulatory authorities that summarizes safety data from all clinical trials of an investigational drug during a defined reporting period. This harmonized reporting format, established under ICH E2F, replaces multiple region-specific annual safety reports with a single, globally accepted document.

For drug safety professionals managing clinical trials across multiple regions, DSUR reporting represents both a standardization opportunity and a compliance challenge. While ICH E2F harmonization reduces redundant reporting, the technical requirements for data aggregation, analysis, and submission remain complex and time-sensitive.

Missing a DSUR deadline or submitting incomplete safety data can result in clinical hold orders, regulatory warnings, and delays to your development timeline. Yet most sponsors struggle with fragmented safety data systems, inconsistent data collection across trial sites, and manual processes that increase error risk.

In this guide, you'll learn:

• ICH E2F DSUR requirements and regulatory expectations across FDA, EMA, and Health Canada
• Step-by-step DSUR preparation process with specific format and content specifications
• Critical DSUR submission timelines and regional regulatory filing procedures
• Common DSUR compliance gaps that trigger regulatory questions and how to prevent them
• Data integration strategies to streamline annual safety reporting and reduce manual effort

What Is DSUR Reporting? [ICH E2F Definition]

Key characteristics of DSUR reporting:

• Annual periodicity: Reports cover a 12-month period from the development international birth date (DIBD), not calendar year
• Integrated analysis: Combines safety data from all ongoing and completed clinical trials of the investigational product
• Harmonized format: Follows ICH E2F structure, accepted by FDA, EMA, Health Canada, PMDA, and most global authorities
• Risk-benefit evaluation: Focuses on evolving safety profile and implications for ongoing trials, not just adverse event listings
• Investigator brochure linkage: Safety findings inform updates to the investigator brochure and trial protocols

The DSUR is required for any investigational product being studied in human clinical trials, from first-in-human studies through post-marketing commitment studies. It remains a regulatory obligation until marketing authorization is granted or clinical development is terminated.

ICH E2F DSUR Requirements and Regulatory Framework

The ICH E2F guideline, "Development Safety Update Report," establishes the international standard for annual safety reporting during clinical development. Understanding these requirements is essential for regulatory compliance across multiple jurisdictions.

ICH E2F Core Principles

The ICH E2F framework is built on several foundational principles that distinguish DSURs from earlier annual report formats:

Conciseness over comprehensiveness: Unlike older IND Annual Reports that included exhaustive data listings, DSURs emphasize concise analysis and interpretation. The report should be under 100 pages excluding appendices, focusing on clinically meaningful safety signals rather than complete data dumps.

Integrated safety evaluation: DSURs require sponsors to analyze safety data across all trials collectively, identifying patterns and signals that might not be apparent in individual study reports. This cross-trial analysis is a core value proposition of the DSUR format.

Risk-benefit focus: The DSUR must address whether the evolving safety profile affects the risk-benefit balance for ongoing trials, not simply catalog adverse events. This forward-looking analysis distinguishes DSURs from retrospective safety summaries.

Investigator communication: Safety findings from the DSUR should inform investigator brochure updates and protocol amendments, creating a continuous improvement loop in clinical trial safety management.

DSUR Format Structure

The ICH E2F guideline specifies a standardized structure for all DSURs:

Regional DSUR Implementation Variations

While ICH E2F harmonized the DSUR format, regional authorities maintain specific submission requirements and procedural differences:

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Critical Compliance Point: Even though DSURs are harmonized, sponsors must still submit separate DSURs to each regulatory authority. A single DSUR document can be used, but submission to FDA does not automatically satisfy EMA requirements - each authority must receive a formal submission.

DSUR Submission Timeline and Critical Deadlines

DSUR timing requirements are among the most commonly misunderstood aspects of development safety reporting. Unlike calendar-year reporting, DSURs follow the development international birth date (DIBD), creating sponsor-specific deadlines.

Development International Birth Date (DIBD)

The DIBD is the date of first approval by any regulatory authority to conduct a clinical trial with the investigational product. This becomes the annual anniversary date for DSUR submissions throughout development.

DIBD determination rules:

• For new molecular entities: First IND/CTA approval date for any trial globally
• For new indications of approved products: First approval for trials in the new indication (not original approval date)
• For new formulations: May use original DIBD or establish new DIBD depending on formulation changes; consult regulatory authority
• For combination products: DIBD of first combination trial if components studied separately previously

Example: If your first IND was approved by FDA on March 15, 2020, your DIBD is March 15. Every year, you must submit DSURs covering the 12-month period ending on or around March 15, with submission due within 60 days (by approximately May 14).

DSUR Submission Deadlines by Region

Different regulatory authorities specify different submission windows after the DIBD anniversary:

Critical timing consideration: The 60-day submission window is calculated from the DIBD anniversary, NOT from the data lock point. Most sponsors establish a data lock point 2-4 weeks before the DIBD anniversary to allow time for analysis and report preparation, meaning the actual analysis window is closer to 30-45 days.

DSUR Preparation Timeline (Recommended)

To meet the 60-day submission deadline, sponsors should follow this backwards-planned timeline:

Common timing failures:

• Starting data collection too late (after DIBD)
• Underestimating time required for cross-trial data integration
• Waiting for "complete" data instead of locking at DIBD
• Insufficient QC time before submission deadline
• Last-minute discovery of missing trial data or exposure calculations

DSUR Content Requirements: Section-by-Section Guide

Each DSUR section has specific content requirements that, when missed, commonly trigger regulatory questions or submission deficiencies.

Section 1: Executive Summary

The executive summary must provide a standalone overview of key safety findings that allows reviewers to quickly assess whether detailed review is needed.

Required content:

• Reporting period: Clearly state DIBD and reporting period dates
• Development phase: Indicate clinical development stage (Phase I, II, III, etc.)
• Exposure summary: Total subjects exposed during reporting period and cumulatively
• Significant findings: 3-5 key safety signals or findings requiring attention
• Safety actions: Major protocol amendments, trial discontinuations, or safety-related changes
• Risk-benefit conclusion: Sponsor's overall assessment of whether trials should continue

Common deficiencies:

• Executive summary exceeding 2 pages (should be 1-2 pages maximum)
• Generic statements without specific data (e.g., "safety profile remains acceptable" without supporting analysis)
• Failure to highlight new safety signals or concerning trends
• Omitting the risk-benefit conclusion required by ICH E2F

Best practice: Write the executive summary last, after completing all analytical sections, to ensure it accurately reflects the full DSUR content.

Section 2: Introduction

The introduction establishes the scope of the DSUR, defining which investigational products and clinical trials are included.

Required content:

• Investigational product identification: Generic name, developmental code, class, mechanism of action
• Indication(s) under investigation: All therapeutic areas and indications being studied
• Approved indication(s): If product is marketed anywhere, state approved indication and countries
• Development phase: Stage of development during reporting period

Defining the "same active substance": ICH E2F requires DSURs to cover all trials of the "same active substance" sponsored by the same entity. This means:

• All formulations (immediate release, sustained release, different strengths)
• All routes of administration (oral, IV, topical, etc.) if same molecule
• All indications being studied for the same molecule

However, separate DSURs are acceptable for:

• Combination products versus single agent (if combination represents distinct regulatory entity)
• Substantially different chemical entities (e.g., different salts with different safety profiles)

Common errors:

• Inconsistent product naming across DSURs and other regulatory submissions
• Unclear scope when multiple indications or formulations exist
• Failure to justify why certain trials are excluded from DSUR scope

Section 3: Worldwide Marketing Authorization Status

This section provides global regulatory context for the investigational product.

Required content if product is marketed anywhere:

• Countries with marketing authorization: Complete list with authorization dates
• Approved indications: Specific therapeutic indications approved in each country
• Significant regulatory actions: Warning letters, safety alerts, label changes, withdrawals
• Post-marketing safety reports: Reference to periodic safety update reports (PSURs) if applicable

Required content if product is not yet marketed:

• Clear statement that product has not received marketing authorization in any country
• Optional: Regulatory designations received (orphan drug, breakthrough therapy, PRIME, etc.)

Common deficiencies:

• Outdated information (using previous year's data without verifying current status)
• Omitting recent regulatory actions or label changes
• Failure to cross-reference PSURs when product is marketed for one indication but investigational for another

Section 4: Actions Taken for Safety Reasons

This section demonstrates proactive safety management by documenting all safety-related actions during the reporting period.

Required content:

• Clinical trials discontinued: Trial number, indication, reason for discontinuation, date
• Clinical trials placed on hold: By sponsor or regulatory authority, with justification
• Protocol amendments: Safety-related changes to inclusion/exclusion criteria, dosing, monitoring
• Dose modifications: Dose reductions, maximum dose changes, dosing schedule alterations
• New warnings or precautions: Additions to investigator brochure, informed consent forms
• New contraindications: Populations excluded from trials based on safety findings

Table format recommended:

Common gaps:

• Omitting protocol amendments that were safety-related but not labeled as such
• Including non-safety actions (efficacy-driven changes, administrative amendments)
• Insufficient detail on rationale for safety actions
• Failure to indicate whether actions were sponsor-initiated versus authority-mandated

Section 5: Changes to Reference Safety Information

Reference safety information (RSI) is the baseline safety document against which adverse events are assessed for expectedness. For investigational products, this is typically the investigator brochure.

Required content:

• Document version: Current investigator brochure version and date
• Changes during reporting period: Specific additions, deletions, or modifications to safety information
• Newly identified adverse drug reactions: Events added to expected adverse reaction profile
• Changes to frequency, severity, or outcome: Updates to existing adverse reaction characterization
• New special warnings: Populations at risk, drug interactions, laboratory monitoring requirements

Example change documentation:

Critical compliance point: Any adverse event classified as "unexpected" based on the RSI at the time of occurrence should be evaluated for expedited reporting (ICSRs). The DSUR documents how the RSI evolved based on accumulated experience.

Section 6: Estimated Exposure

Accurate exposure estimation is essential for denominator calculations and safety rate assessments.

Required exposure metrics:

• Number of subjects: Broken down by indication, trial phase, age group, sex
• Subject-time exposure: Subject-years, subject-months, or subject-treatment courses
• Dose exposure: Number of subjects at each dose level or dose range
• Cumulative exposure: All-time exposure from first trial to end of reporting period

Recommended exposure table format:

Common exposure calculation errors:

• Double-counting subjects enrolled in multiple trials during reporting period
• Inconsistent exposure units (mixing subject-years and subject-months)
• Failure to account for subjects who withdrew early (exposure time-based calculations needed)
• Cumulative exposure not reconciling with previous DSUR totals plus current period additions

Section 7: Presentation of Individual Case Safety Reports

This section references the appendix containing line listings of serious adverse events but should include a brief summary in the body.

Required summary content:

• Total SUSARs: Suspected unexpected serious adverse reactions requiring expedited reporting
• Fatal events: Number and percentage of subjects with fatal outcomes
• Life-threatening events: Number and brief characterization
• Hospitalization events: If significantly elevated versus expected
• Other serious outcomes: Disability, congenital anomaly, medically important events

Required appendix listings:

• Line listing of all serious adverse events (SAEs) during reporting period
• Line listing of all SUSARs during reporting period
• Listings should include: subject ID, age, sex, trial number, event term, onset date, outcome, causality assessment

Best practice: Reference the appendix explicitly (e.g., "See Appendix A: Line Listing of Serious Adverse Events") and provide page numbers for easy navigation.

Section 8: Summaries of Significant Findings

This is the core analytical section where sponsors demonstrate integrated safety analysis across trials.

Required analysis components:

New safety signals: Events or patterns not previously identified, with supporting data:

• Event description and clinical presentation
• Frequency across trials and dose groups
• Temporal relationship to treatment
• Biological plausibility and mechanism
• Causality assessment and confounding factors
• Implications for ongoing trials

Updating known risks: Changes in frequency, severity, or characterization:

• Comparison to previous reporting periods
• Dose-response relationships
• Population subgroups at higher risk
• Risk mitigation measures implemented

Special populations analysis:

• Elderly, pediatric, pregnant/lactating (if applicable)
• Renal or hepatic impairment
• Drug-drug interactions observed
• Ethnic or geographic variations

Deaths: Detailed analysis of all fatal outcomes:

• Narratives of death circumstances
• Investigator and sponsor causality assessment
• Contributing factors and confounders
• Pattern analysis if multiple deaths

Best practice analysis approach: Use structured signal evaluation methodology:

1. Signal detection: Identify potential signals through disproportionality analysis, temporal patterns, or clinical review
2. Signal validation: Assess data quality, causality, biological plausibility
3. Signal confirmation: Determine if signal represents true drug-related risk
4. Signal characterization: Define frequency, severity, risk factors, reversibility
5. Action determination: Decide on investigator brochure updates, protocol amendments, or regulatory notifications

Section 9: Overall Safety Evaluation

The final section provides the sponsor's integrated assessment and risk-benefit conclusion.

Required content:

• Safety profile characterization: Overall description of the safety profile based on all data
• Changes from previous DSUR: How the safety understanding has evolved
• Risk-benefit assessment: Whether known and potential risks remain acceptable relative to therapeutic benefit
• Implications for ongoing trials: Whether trials should continue as designed or require modification
• Investigator brochure adequacy: Whether current IB adequately characterizes risks

Risk-benefit conclusion examples:

Positive risk-benefit (trials continue):

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"Based on integrated analysis of 1,940 subjects exposed to ABC-123, the safety profile remains consistent with the known pharmacology and therapeutic class. New signals identified (hepatotoxicity, QT prolongation) are manageable with appropriate monitoring and dose adjustments. Given the significant efficacy demonstrated in Phase 2 studies for a serious unmet medical need, the benefit-risk profile supports continuation of Phase 3 development with enhanced hepatic and cardiac monitoring."

Negative risk-benefit (development termination):

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"Analysis of serious adverse events during the reporting period identified an unacceptable frequency of thrombotic events (5% incidence across Phase 2 trials), including 3 fatal pulmonary emboli. Given the availability of alternative therapies for the target indication and the severity of the thrombotic risk, the sponsor has determined the benefit-risk profile is unfavorable and has discontinued clinical development of ABC-123."

DSUR Formatting and Submission Requirements

Proper formatting and submission packaging prevent technical rejections and ensure efficient regulatory review.

Document Format Standards

DSURs should follow these formatting specifications:

eCTD Submission Format

For regulatory authorities requiring eCTD submission (FDA, many European agencies), the DSUR must be submitted as part of a structured eCTD sequence.

eCTD Module 1 placement (Region-specific):

• FDA: Module 1.5.2 - IND Annual Reports
• EMA: Module 1.8 - Development Safety Update Report

Backbone file structure:

Sequence numbering: DSURs are typically submitted as Type 5 submissions (IND safety reports) with incrementing sequence numbers (0001, 0002, 0003...).

Regional Submission Methods

Quality Control Checklist Before Submission

Complete this QC checklist before final submission:

• [ ] All required ICH E2F sections present and complete
• [ ] Executive summary is concise (1-2 pages) and standalone
• [ ] DIBD and reporting period dates are accurate and consistent throughout
• [ ] Exposure calculations reconcile with previous DSUR cumulative totals
• [ ] All SAE and SUSAR listings are complete and match narrative descriptions
• [ ] Cross-references between sections are accurate (e.g., "see Section 8" links)
• [ ] Table of contents page numbers match actual section locations
• [ ] Causality assessments are consistent for same events across different sections
• [ ] Investigator brochure version cited is current and matches safety information changes
• [ ] Risk-benefit conclusion is explicitly stated in overall safety evaluation
• [ ] Appendices are clearly labeled and referenced in main text
• [ ] Document is paginated consecutively
• [ ] Headers/footers include product name, reporting period, sponsor
• [ ] All tables and figures are legible and properly formatted
• [ ] eCTD backbone structure follows regional specifications
• [ ] File naming conventions match regulatory requirements
• [ ] Digital signature/certificate is valid for submission gateway
• [ ] Cover letter references correct IND/CTA numbers and submission type

Common DSUR Compliance Gaps and How to Prevent Them

Regulatory authorities frequently identify the same compliance issues across DSUR submissions. Understanding these common gaps allows sponsors to implement preventive measures.

Gap 1: Inadequate Integrated Safety Analysis

The Problem: Sponsors present trial-by-trial safety summaries rather than integrated cross-trial analysis, failing to identify patterns only visible when data is combined.

Regulatory expectation: ICH E2F requires "concise, critical analysis" across all trials, not simply aggregated listings. Reviewers expect sponsors to actively look for safety signals, not just report what individual trials showed.

Examples of inadequate analysis:

• Listing SAE frequencies for each trial separately without combined analysis
• Failing to identify that hepatotoxicity occurred in 5% of subjects across three trials, though no single trial showed significant signal
• Not analyzing whether serious infections cluster in certain dose groups or patient populations when data is combined

How to prevent:

• Establish a cross-functional safety review team (medical monitor, biostatistician, regulatory) to analyze integrated data
• Use standardized MedDRA coding across all trials to enable cross-trial analysis
• Implement disproportionality analysis (PRR, ROR, or EBGM methods) to detect signals
• Create combined safety databases that pool all trial data before analysis
• Compare current reporting period signal detection to previous period to identify emerging patterns

Gap 2: Incomplete or Inaccurate Exposure Data

The Problem: Exposure estimates don't account for early withdrawals, use inconsistent denominators, or don't reconcile with prior DSURs.

Regulatory impact: Inaccurate exposure data invalidates all safety rate calculations and prevents meaningful risk assessment. FDA may issue information requests or refuse to file deficient DSURs.

Common exposure errors:

• Counting all enrolled subjects as "exposed" even if they never dosed or withdrew after one dose
• Using different exposure metrics (subjects vs. subject-years) inconsistently across sections
• Cumulative exposure totals in current DSUR don't equal previous DSUR cumulative total plus current period new subjects
• Failing to stratify exposure by dose level when dose-related toxicity is known

How to prevent:

• Define exposure calculation methodology in a DSUR SOP and apply consistently year-over-year
• Use actual treatment duration data from clinical databases, not planned trial duration
• Implement automated exposure calculations from clinical trial management systems
• Reconcile cumulative exposure with prior DSUR before finalizing current report
• Maintain a "subject accounting" table showing subjects from previous DSURs, new subjects this period, and cumulative total

Best practice exposure metric: Subject-years of exposure accounts for varying treatment durations and allows standardized incidence rate calculations:

Gap 3: Missing or Delayed Safety Actions

The Problem: Sponsors fail to document protocol amendments or IB updates that were actually safety-driven, or implement changes months after safety signals were identified.

Regulatory expectation: Timely action on safety signals demonstrates good pharmacovigilance practice. Delays suggest inadequate safety monitoring or responsiveness.

Examples of concerning delays:

• Safety signal identified in Month 2 of reporting period, but protocol amendment not implemented until Month 11
• Investigator brochure not updated to reflect new adverse reactions until next scheduled IB revision, 6 months after signal detection
• Multiple subjects experienced hypersensitivity reactions, but desensitization protocols not added until regulatory authority asked about it

How to prevent:

• Establish internal timelines for safety action: signal detection → medical review → decision → implementation within 30-60 days
• Document reasons for any delays in taking safety actions (e.g., "Amendment delayed pending DMC review")
• Implement "interim" IB updates for significant new safety information, not just annual full revisions
• Track safety actions in real-time dashboard accessible to medical monitors and regulatory team
• Include "safety action decision log" in DSUR showing when signals were detected, when decisions made, when actions implemented

Gap 4: Inadequate Signal Evaluation and Follow-up

The Problem: Potential safety signals are noted but not thoroughly investigated, or concerning patterns are dismissed without sufficient justification.

Regulatory concern: Superficial signal evaluation may miss true drug-related risks, jeopardizing subject safety in ongoing trials.

Examples of inadequate signal evaluation:

• "Three cases of acute pancreatitis occurred across trials. Causality is unclear." (No analysis of temporal relationship, dose-response, alternative causes, or biological plausibility)
• Increased infection rate observed but attributed to underlying disease without exploring dose-relationship or immune function testing data
• Imbalance in cardiovascular events noted but not investigated further because none were assessed as "definitely related" by investigator

How to prevent:

• Implement structured signal evaluation framework for all potential signals:

1. Data quality check (Are cases well-documented? MedDRA coding consistent?)

2. Frequency analysis (Rate in exposed vs. comparator or general population?)

3. Temporal analysis (Time to onset consistent with drug exposure?)

4. Dose-response assessment (Higher rates at higher doses?)

5. Biological plausibility (Known pharmacology or class effect?)

6. Dechallenge/rechallenge data (Did events resolve on discontinuation? Recur on restart?)

7. Literature review (Other drugs in class show similar signal?)

8. Confounding factors (Underlying disease, concomitant meds, alternative explanations?)

• Convene ad hoc safety meetings with independent experts for concerning signals
• Document full signal evaluation rationale even if signal is ultimately dismissed
• Implement enhanced monitoring for potential signals in ongoing trials while evaluation continues

Gap 5: Inconsistent Causality Assessment

The Problem: Causality assessments for the same event vary across trials, reviewers, or time periods without clear justification.

Regulatory impact: Inconsistent causality undermines confidence in sponsor's safety analysis and may indicate inadequate medical review processes.

Examples:

• Hepatotoxicity in Trial A assessed as "related"; similar cases in Trial B assessed as "unlikely related" despite similar presentation
• Investigator causality differs from sponsor causality in >50% of cases without documented rationale
• Events initially assessed as "unrelated" are reclassified as "related" in subsequent DSURs without explaining what new information changed the assessment

How to prevent:

• Implement standardized causality assessment algorithm (WHO-UMC, Naranjo, or sponsor-specific validated method) applied consistently across all trials
• Conduct blinded causality review by medical safety physicians who don't know investigator's initial assessment
• For sponsor-investigator causality disagreements, document specific reasons (e.g., "Investigator assessed as unrelated due to underlying cirrhosis; sponsor assessed as related based on temporal relationship and lack of alternative explanation")
• Maintain "causality decisional framework" documenting criteria for each causality category
• Re-train investigators and safety reviewers annually on causality assessment standards

Gap 6: Late Submission or Inadequate Justification for Delays

The Problem: DSUR submitted after 60-day deadline without prior notification or acceptable justification.

Regulatory consequences: FDA may place clinical trials on hold for late DSURs. EMA may issue compliance findings. Delays signal inadequate regulatory infrastructure.

Acceptable delay justifications:

• Unexpected serious data integrity issues discovered during DSUR preparation requiring data verification (notify authority immediately)
• Change in sponsor ownership during reporting period causing administrative delays (notify authority, provide updated timeline)
• Force majeure events (natural disasters, pandemics) affecting sponsor's ability to compile DSUR

Unacceptable excuses:

• "We didn't have enough staff to finish on time"
• "Data collection took longer than expected"
• "We were waiting for the final trial report"

How to prevent:

• Establish DSUR preparation timeline starting 60 days before DIBD, not at DIBD
• Implement project management tracking with milestone dates and responsible parties
• Lock data at DIBD even if some trial data is incomplete; document limitations rather than delay submission
• If delay is unavoidable, notify regulatory authority before deadline with explanation and revised submission date
• Consider submitting preliminary DSUR on time with supplemental information to follow, if authority permits

DSUR Data Management and System Integration Strategies

Efficient DSUR preparation requires integrated data systems that can pull safety data from multiple trials and databases. Manual processes create bottlenecks and increase error risk.

Data Sources for DSUR Compilation

A complete DSUR requires data aggregation from multiple systems:

Manual vs. Automated DSUR Preparation

ROI calculation for automation:

• Manual DSUR preparation: 100 hours × $150/hour burdened cost = $15,000 per DSUR
• Automated system implementation: $50,000-$150,000 one-time + $10,000/year maintenance
• Break-even: 3-10 DSURs depending on trial complexity
• Additional value: Reduced regulatory risk from consistent methodology and completeness

Integration Strategy Recommendations

For small sponsors (1-3 trials):

• Use standardized Excel templates with built-in formulas for exposure and incidence calculations
• Establish data extract specifications with CROs to ensure consistent data delivery
• Implement basic data validation rules (e.g., cumulative exposure must ≥ prior year + current year)
• Consider contracting with regulatory writing consultants who have DSUR expertise and templates

For mid-size sponsors (4-10 trials):

• Implement safety database that integrates with EDC systems (Argus, ARISg)
• Use Clinical Data Warehouse to centralize data from multiple trials
• Develop automated SAS or R programs to generate standard DSUR tables
• Create company-specific DSUR template in structured authoring tool (eCTD submission-ready format)

For large sponsors (10+ trials):

• Full integration between safety database, EDC, CTMS, and regulatory information management
• Automated DSUR generation with medical review workflow built into system
• Real-time safety monitoring dashboards that surface signals proactively
• Dedicated pharmacovigilance team with DSUR sub-team and established SOPs

Key Takeaways

Next Steps

Preparing compliant, high-quality DSURs requires integrated data systems, standardized methodologies, and sufficient time for thorough safety analysis. Many sponsors struggle with fragmented clinical trial data, manual data aggregation processes, and last-minute DSUR preparation timelines that increase error risk.

Organizations managing regulatory submissions benefit from automated validation tools that catch errors before gateway rejection. Assyro's AI-powered platform validates eCTD submissions against FDA, EMA, and Health Canada requirements, providing detailed error reports and remediation guidance before submission.

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