Manual Authoring
- Data analyzed separately from document writing
- Copy-paste from Excel into Word templates
- Manual figure creation and table formatting
- Multiple rounds of QC to catch transcription errors
- Broken traceability from data to document
- 12-16 weeks from data lock to submission
ArcaScience Generation
- Documents generated directly from analytical pipeline
- Every table, figure, and statistic auto-populated
- Regulatory format templates built-in (ICH, FDA, EMA)
- Zero transcription errors — data flows directly to output
- Complete traceability from raw data to final document
- 2-5 days from data lock to submission-ready document
Five Regulatory Output Types
Submission-Ready Documents for Every Stage of the Lifecycle
Each output type is formatted to regulatory agency specifications with complete data traceability and audit trail.
PSUR / PBRER
ICH E2C(R2) aligned. Automated integration of interval and cumulative safety data. Hours vs 12-16 weeks manual.
Sections Auto-Generated
- Executive summary
- Worldwide marketing authorization status
- Actions taken for safety reasons
- Changes to reference safety information
- Estimated exposure and use patterns
- Data summary (interval and cumulative)
- Signal evaluation
- Benefit-risk evaluation and conclusions
Regulatory Compliance
- ICH E2C(R2) format compliance
- MedDRA version control
- WHO-ART to MedDRA mapping
- Data lock point documentation
- IBD (International Birth Date) calculation
- Cumulative data reconciliation
- Appendix auto-population (line listings, case summaries)
Generation time
Data accuracy
Transcription errors
Risk Management Plans
EMA GVP Module V. Safety specification, PV plan, risk minimization measures.
Part I: Product Overview
Auto-populated from regulatory database and product master file.
Part II: Safety Specification
Epidemiology, non-clinical, clinical safety data synthesized from AS Profiling Base.
Part III: Pharmacovigilance Plan
Routine PV activities, additional PV activities, milestones, post-authorization studies.
Part IV: Risk Minimization
Routine risk minimization (SmPC, labeling), additional risk minimization measures.
Part V: Summary of RMP
High-level overview for public disclosure, automatically formatted.
Annexes
Protocol summaries, PASS/PAES details, educational materials, all auto-linked.
Compliant with EMA GVP Module V and FDA REMS requirements
CTD Module 2.5
ICH M4E structure. Benefit-risk conclusions from quantitative framework. NDA/BLA/MAA ready.
Clinical Overview Sections
- 2.5.1 Product Development Rationale — Disease background, unmet medical need, benefit-risk considerations guiding development
- 2.5.2 Overview of Biopharmaceutics — Auto-populated from CMC and clinical pharmacology
- 2.5.3 Overview of Clinical Pharmacology — PK, PD, drug interactions, special populations
- 2.5.4 Overview of Efficacy — Primary and secondary endpoints across pivotal trials, effect sizes, subgroup analyses
- 2.5.5 Overview of Safety — Integrated safety summary with exposure-adjusted rates, signal detection, causality assessment
- 2.5.6 Benefit-Risk Conclusions — Quantitative benefit-risk framework with MCDA, effects tables, value trees, scenario modeling
- 2.5.7 Literature References — Auto-generated bibliography with in-text citations
Every statistic, table, and figure in CTD 2.5 traces back to source data with complete audit trail. Regulatory reviewers can verify calculations with one click.
HEOR Reports
Value dossiers, comparative effectiveness, payer evidence for NICE, G-BA, HAS, CADTH, PBAC.
Value Dossiers
AMCP Format dossiers for US payers. Clinical, economic, and humanistic outcomes. Budget impact models and cost-effectiveness analyses.
AMCP Format 4.1 compliant
HTA Submissions
NICE Single Technology Appraisal, G-BA early benefit assessment, HAS transparency commission, CADTH Common Drug Review, PBAC submissions.
Supports all major HTA bodies
Comparative Effectiveness
Network meta-analysis for indirect comparisons. Real-world evidence comparative effectiveness studies. MAIC (matching-adjusted indirect comparison) and STC (simulated treatment comparison).
ISPOR best practices
Economic Models
Cost-effectiveness models (CEA), cost-utility analysis (CUA), budget impact models (BIM). Markov models, discrete event simulation, partitioned survival.
CHEERS 2022 compliant reporting
Signal Detection Reports
Disproportionality analysis, NLP-based detection, automated signal scoring.
Continuous Monitoring
Weekly, monthly, or event-triggered signal detection runs with automated alerts for threshold exceedance.
Disproportionality Metrics
PRR, ROR, EBGM, IC with 95% confidence intervals. Multi-item analysis for drug-event combinations.
Prioritization Scoring
Automated signal prioritization based on seriousness, novelty, clinical significance, and regulatory impact.
Configurable reporting cadence — weekly, monthly, or event-triggered. Full audit trail for regulatory inspection readiness. Every signal links back to source cases with one click.
Quality Assurance
Four-Layer Validation Before Output Generation
Every automated output undergoes programmatic validation before release to ensure regulatory compliance and data accuracy.
Cross-Reference Validation
Every statistic is checked against source data. Tables cross-referenced with text. Figures verified against underlying data. Internal consistency checks for cumulative vs interval data.
Data Currency Checks
Automated verification that all data sources are up-to-date. MedDRA version consistency. Data lock point documentation. Regulatory database snapshot timestamps.
Regulatory Format Validation
ICH, FDA, EMA format compliance checks. Required sections present and complete. Numbering and referencing consistency. Appendix cross-references validated.
Audit Trail Verification
Complete data lineage from raw data to output. User actions logged with timestamp and rationale. Version control for all analytical decisions. 21 CFR Part 11 compliant audit trail.
Submissions Accepted
FDA, EMA, PMDA approvals
Time Reduction
vs manual authoring
Transcription Errors
Data flows directly to output
Audit Trail
Full traceability