Systematic Reviews for Evidence-Based Drug Development and Market Access
Systematic reviews underpin every stage of drug development and market access, from pre-clinical evidence mapping to post-approval surveillance. Puraite automates the evidence synthesis workflow to regulatory standard with a complete audit trail.
Request a Pharma WalkthroughThe Challenge
Why systematic reviews are mission-critical across the pharmaceutical value chain.
Regulatory Submissions
Agencies including the FDA and EMA require comprehensive, reproducible literature reviews demonstrating a drug's safety and efficacy profile before approval. Manual processes struggle to keep pace with parallel submissions across multiple markets and indications.
Health Technology Assessment (HTA)
To secure reimbursement, pharmaceutical companies must present systematic reviews to HTA bodies, IQWiG and G-BA in Germany, NICE in the UK, HAS in France, demonstrating added therapeutic benefit versus appropriate comparators. Each body has specific methodological expectations.
Pharmacovigilance & Signal Detection
EU pharmacovigilance legislation (Directive 2001/83/EC, Regulation 726/2004) and FDA post-marketing requirements mandate continuous, systematic monitoring of published literature to identify adverse events and long-term safety signals.
R&D Strategy & Trial Design
Before committing to clinical trials, companies use systematic reviews to identify unmet medical needs, map the competitive evidence landscape, inform endpoint selection, and optimise trial design parameters including historical control event rates.
How Puraite Helps
Specific workflows where Puraite accelerates regulated evidence work.
AMNOG Dossier Preparation
Automated PICO definition, systematic literature search across MEDLINE, EMBASE and Cochrane Library, risk-of-bias assessment and PRISMA flow generation for Module 4 evidence tables. Documentation structured to meet IQWiG's Allgemeine Methoden requirements.
NICE Technology Appraisal Support
Systematic search strategy development, dual screening with AI-assisted conflict resolution, and structured data extraction aligned with NICE's methods and process guide. Transparent documentation of every inclusion and exclusion decision.
Global HTA Submissions
Single-source evidence synthesis exportable to multiple dossier formats. Puraite maintains jurisdiction-specific PICO templates covering G-BA/IQWiG, NICE, HAS, CADTH, and PBAC requirements, enabling evidence reuse across markets.
Indirect Treatment Comparison (ITC) Inputs
Systematic evidence mapping for network meta-analysis. Structured identification and PICO tagging of relevant RCTs and observational studies with export to NMA software formats (R netmeta, WinBUGS, OpenBUGS).
Generating a complete, audit-ready PRISMA flow and evidence table used to take our team the better part of two months. With Puraite, we had a defensible first draft within weeks, and the AI rationale was exactly the kind of traceability the G-BA process demands.
Head of HEOR, Global Pharmaceutical Company
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