Comprehensive approach to achieve clinical differentiation through stronger value propositions by exploring patient outcomes beyond clinical efficacy and safety
Evidence Reviews and Synthesis
- HTA compliant systematic literature reviews to generate evidence for meta-analysis/ indirect treatment comparisons for external submissions
- Disease area reviews and pragmatic reviews for internal decision making and clinical trial planning
- Landscape reviews for forecasting and competitive intelligence
Market Access Strategy
- Global/Core Value Dossiers
- Academy of Managed Care Pharmacy (AMCP) Dossiers
- HTA submissions (UK-NICE, PBAC, CADTH, country-specific adaptations)
- Unique value propositions
- External stakeholder engagement
Medical Writing Support
- Real-world Evidence Reports (Database and registry studies)
- Publication Planning and Manuscript writing assistance
- Regulatory Writing
- Technical reports (ICH E3 Compliant Clinical Study Reports), Clinical Summaries
- Safety reports (development safety update reports (DSURs), periodic safety update reports (PSURs) and annual safety reports (ASRs)
- Clinical Study Protocol Development
- Payer Reports
Market Research
- HTA monitoring and analysis (NICE, SMC, HAS, IQWiG, PBAC, CADTH)
- Clinical Guideline Reviews
- KOL Mapping
- Focus groups interviews
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