Description

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Systematic Review & Meta-Analysis (Industry-Sponsored)

Comprehensive evidence synthesis supporting regulatory submissions, label claims, and health technology assessments. PRISMA 2020-compliant systematic reviews with quantitative meta-analysis.

Compliance Framework

• PRISMA 2020 – Reporting guideline
• Cochrane Handbook – Methodological standards
• GRADE – Evidence quality assessment
• GPP3 – Industry-sponsored review ethics
• PROSPERO – Protocol registration

Deliverables

• PROSPERO-registered protocol
• Comprehensive search strategy (MEDLINE, Embase, Cochrane, etc.)
• Study selection with PRISMA flow diagram
• Data extraction tables
• Risk of bias assessment (Cochrane RoB 2, ROBINS-I)
• Meta-analysis with forest plots
• Heterogeneity and sensitivity analyses
• Publication bias assessment
• GRADE evidence summary tables
• Full manuscript (journal-ready)

Applications

• Regulatory submission support (Module 2.5)
• HTA dossiers
• Label expansion evidence
• Competitive positioning
• Guideline development support

Timeline

Standard: 16-24 weeks | Rapid review: 8-12 weeks

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