Accelerating Access by Demonstrating True Value of Innovation
For access, pricing, HEOR, and regulatory teams shaping value-based healthcare
Your Strategic Roadblocks

Demonstrate Drug Value effectively
To gain regulatory
and HTA acceptance

Maximize Reimbursement Chances
By aligning clinical insights with
real-world evidence

Accelerate Access Timelines
While maintaining high
standards of evidence
Our Solutions
We deliver data-driven solutions to support approval, reimbursement, and pricing strategies with scientifically sound, real-world-aligned evidence
Support to Regulatory Approval
Secure confidence from regulatory authorities with robust, AI-enhanced evidence
• Systematic Literature Review (SLR) & automated safety reporting
• Predictive safety modeling for early signal detection
• High-value patients’ identification using real-world and clinical datasets
• Long-term benefit risk simulation
• Disease burden characterization to contextualize unmet need
Medical Value Demonstration
& Differentiation
Make your value proposition stand out with metrics that resonate
• PRO data analysis and optimal metric selection for HTA dossiers
• Long-term outcomes prediction bridging efficacy and effectiveness
• Surrogate endpoints validation
• Identification of high-value patients across RCT and RW data
Augmented Evidence Generation
Complement traditional evidence with simulated and synthetic insights
• Synthetic control arms to reduce reliance on placebo arms and historical
data
• In-silico cohorts for exploratory or hard-to-reach subpopulations
• Digital twins modeling to simulate long-term outcomes or rare scenarios
• Treatment effect extrapolation
Your Benefits


More persuasive evidence for regulatory and HTA acceptance
With scientifically sound modeling, safety insights, and unmet need quantification

Faster and de-risked regulatory submission
Thanks to automated literature reviews, target population sizing, and predictive safety analysis

Reduced evidence generation burden
Via synthetic control arms, in-silico simulations, and real-world-based modeling

More targeted, impactful pricing & reimbursement strategies
With refined patient segmentation and
data-backed value differentiation
See Our Solutions in Action
Rare Diseases
Extending Randomized Controlled Trials (RCT) Insights to Real-World Outcomes

Cardiovascular Diseases
Simulating Real-World Effectiveness for a New Therapy
Discover how we projected real-world treatment impact before market adoption

Challenge
- New Treatment, Limited Data: A novel therapy had no real-world effectiveness data
- Need for Evidence-Based Positioning: Simulate treatment impact to guide best practices and support prescribers and authorities

Our Solution
Hybrid Real-World Data (RWD) - Randomized Controlled Trials (RCT) Modeling: Estimated survival under standard-of-care using RWD, then applied RCT treatment effects under various therapy positioning scenarios

Results and Impact
Confirmed treatment benefits consistent with RCT outcomes
Identified and highlighted a treatment effect modifier
Provided actionable insights on treatment effectiveness pre market

Rare Diseases
Extending Randomized Controlled Trials (RCT) Insights to Real-World Outcomes
See how we bridged RCT efficacy data to real-world effectiveness to support strategic treatment launch

Challenge
- Fragmented Data Sources: Registries and Real-World Data (RWD) catalogs are scattered, making identification and assessment time-consuming
- Need for Extended Insights: Understand treatment impact on real-world outcomes to anticipate post-authorization studies and prepare launch strategy

Our Solution
External Control Arm (ECA):
- Replicated RCT inclusion/exclusion criteria in external databases
- Weighted ECA to match patient characteristics
- Estimated treatment effect on selected real-world outcomes

Results and Impact
- Implemented automated extraction and structuring from +200k papers, +250 registries, +10k observational studies
- Hazard ratio of 0.33 vs. adjusted ECA → 67% risk reduction over time
- Provided robust evidence supporting launch and regulatory discussions

Whether you need to secure regulatory approval, craft a compelling HTA dossier, or simulate long-term outcomes for payers, we’re here to help

Let’s Build Your Next Evidence Strategy
Whether you need to secure regulatory approval, craft a compelling HTA dossier, or simulate long-term outcomes for payers, we’re here to help