Aetion
Evidence at scale
Generating quality real-world evidence (RWE) at scale can be challenging. As data sources grow in complexity and regulatory standards continue to evolve, scientific, regulatory, and technological expertise is necessary to facilitate the strategic use of RWE throughout the product lifecyle.
Proven scientific expertise
Driven by 100+ scientists with decades of academic, industry, and regulatory experience, our scientific services team advises clients on the most effective ways to streamline and accelerate evidence generation across their assets and portfolios, while ensuring adherence to RWE best practices through every step of the process.
Proven regulatory expertise you can trust
Regulatory agencies expect evidence packages to include quality RWE to support safety and effectiveness claims. Aetion is the standard-setter that clients rely upon to evaluate regulatory feasibility, design fit-for-purpose real-world studies and conduct fit-for-purpose feasibility assessments thereby ensuring the highest probability of success for regulatory submissions.
Natural History Studies
Describe outcome risk in patients receiving standard of care and identify subgroups with risk variation to support trial design or argument for non-randomized pivotal study design
Real-Time Adverse Event Contextualization
Describe background safety event rates to support interpretation of safety imbalances observed in trails
External Control Arm
Provide comparison data for single-arm trial to support claims of treatment effectiveness/safety for regulatory decision-making
Post- approval Safety (PASS/PMR)
Identify and evaluate post-approval safety signals to fulfill regulatory obligations
Comparative Effectiveness and Safety
Describe and compare post-marketing effectiveness and safety risks in patients receiving treatment of interest and standard of care/comparator to fulfill regulatory requirements and support formulary/pricing decision-making
RWE for Cost Effectiveness
Describe and compare costs of healthcare utilization in patients receiving treatment of interest and standard of care/comparator to support formulary/pricing decision-making
Research & Development
Generate regulatory-grade evidence in support of new drug and biologic license applications. Inform key decisions that direct trial design, value story development and competitive market analysis.
- Addressable Market
- Patient Characteristics
- Burden of Disease
- Unmet Therapeutic Need
- Data Amplification and Augmentation
- Healthcare Utilization and Cost
- Treatment Pathways
- Standards of Care
- External Control Arm
- Trial Emulation
- Real-Time Adverse Event Contextualization
- Label Expansion
- Natural History Studies
- Post-Approval Safety (PASS/PMR)
Commercialization
Monitor real world utilization and market share, use data to inform payer conversations and formulary placement. Publication-ready HEOR and HTA analyses to support global value dossier and HCP interaction.
- Patient Journey
- Real-world Utilization
- Adherence and Persistence
- Investigate Potential Adverse Events
- HCP Preferences
- Out-of-Pocket Costs
- RWE for Cost Effectiveness
- Comparative Effectiveness and Safety
- Predict High-Risk Patients for Intervention
- Optimize Formulary/Benefit Designs
- Evaluate and Optimize Clinical Programs