Epifractals delivers regulatory-grade RWE, HEOR, and AI solutions that accelerate drug development, secure market access, and improve patient outcomes.
Epifractals was founded to help life sciences companies navigate the new reality where Real-World Evidence, Health Economics, and Artificial Intelligence are no longer optional — they are essential.
We are a lean, responsive team of epidemiologists, health economists, biostatisticians, and data scientists with deep expertise in advanced modeling (Markov, Microsimulation), systematic reviews, and real-world evidence. Our clients value our speed, competitive pricing, methodological rigor, and ability to deliver high-quality work on tight HTA and regulatory timelines.
We combine strong domain knowledge in public health and health economics with technical proficiency in R, Python, R-Shiny, Stata, and AI-assisted tools to deliver evidence that supports market access, HTA submissions, and policy decisions globally.
Regulators, payers, and healthcare providers now demand robust evidence of a therapy’s value, effectiveness, and safety in real-world settings across the entire product lifecycle.
Data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources — EHRs, claims data, patient registries, wearables, and digital health technologies.
Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. Increasingly accepted by FDA, EMA, and HTA bodies for regulatory and reimbursement decisions.
A discipline that evaluates the economic, clinical, and humanistic outcomes of healthcare interventions to inform decision-making for payers, providers, and patients — essential for value demonstration and market access.
FDA and EMA have formalized expectations and structured programs for RWE use in approvals, label expansions, and post-marketing commitments.
Payers are raising the bar. Compelling economic and outcomes data is now mandatory for favorable reimbursement and market access decisions globally.
Wearables, smartphone sensors, and connected devices are generating continuous real-time real-world data at unprecedented scale and granularity.
From early development through post-launch, Epifractals helps generate the evidence regulators and payers require.
Quantifying incidence, prevalence, and disease trajectories to prioritize indications and inform target product profiles.
Using historical RWD to simulate eligibility criteria, estimate screen failure rates, and anticipate recruitment bottlenecks before trials begin.
Leveraging EHR, claims data, and registries to understand patient populations and optimize study locations for speed and diversity.
Machine learning and generative AI are no longer experimental — they are production-grade tools that dramatically improve speed, depth, and quality of evidence.
NLP and LLMs extract diagnoses, treatments, outcomes, and phenotypes from clinical notes, radiology reports, and pathology documents at scale — building computable, harmonized datasets across institutions.
Advanced ML improves confounding adjustment, predictive modeling for treatment response and adverse events, and exploration of heterogeneous treatment effects across complex patient subgroups.
Generative AI accelerates systematic literature reviews, data extraction, report drafting, and model harmonization — always with rigorous human oversight, validation, and regulatory-grade documentation.
We partner with organizations across the life sciences value chain to generate evidence that drives better decisions and patient outcomes.
We prioritize high-impact services that drive market access and regulatory success: Systematic Literature Reviews & Network Meta-Analysis, HEOR studies (Cost-effectiveness, Budget Impact, Microsimulation), and Real-World Data analysis & Tool development.
The Foundation of Intelligent Decision-Making
We transform complex data into actionable intelligence. Our team employs rigorous methodologies to synthesize clinical, epidemiological, and operational data, providing the clarity needed to navigate complex healthcare challenges.
Navigating the Evidence Landscape
In a crowded market, understanding your product’s relative standing is critical. We specialize in indirect treatment comparisons to showcase your value proposition against competitors.
Navigating the Regulatory and Reimbursement Maze
Securing market access requires more than clinical data; it requires a compelling, evidence-based narrative. We develop robust HTA dossiers that meet the stringent requirements of global agencies.
Demonstrating Financial Value
Value in healthcare is defined by both clinical outcomes and economic impact. We provide the financial analytics required to demonstrate cost-effectiveness and budget sustainability.
Ensuring Lifetime Safety
The journey of a medical product continues long after market launch. We offer comprehensive safety surveillance solutions to monitor, detect, and evaluate adverse events.
Understanding the Human Dimension
Healthcare decisions have profound social and ethical implications. We assess the wider impacts of health technologies, policies, and programs on communities, equity, and the environment.
Shaping the Future of Healthcare
We bridge the gap between data and decision-making. Our work supports policymakers and health leaders in designing efficient, equitable, and evidence-based health systems.
Modernizing Traditional Wisdom
We apply the rigorous scientific framework of HTA to validate and mainstream traditional and alternative medical systems, fostering their integration into the broader healthcare ecosystem.
Building the Next Generation of Evidence Makers
We are committed to fostering expertise in Health Technology Assessment. We offer tailored training programs to equip professionals with the skills to conduct and critique HTA.
Our multidisciplinary team is ready to assist you. Whether you need a full-scale HTA dossier, a complex meta-analysis, or a capacity-building workshop — let's discuss your project.
High-stakes decisions require more than data — they require rigor, transparency, and interdisciplinary expertise.
Every study begins with a precise research question. We ensure data sources and study designs are appropriate, defensible, and aligned with regulatory and payer expectations.
Clear lineage, quality checks, and documentation at every step. We maintain audit-ready records of data origin, transformations, and decisions.
Findings are rigorously tested. We conduct extensive sensitivity analyses and stress-test assumptions to ensure robustness of conclusions.
Our teams combine clinical operations expertise, deep RWD methodologists, health economists, and AI/ML specialists — working as one integrated unit.
We are a specialized collective of epidemiologists, health economists, and implementation scientists. Our core arsenal includes HEOR, advanced evidence synthesis (NMA and systematic reviews), biostatistics, and GIS‑driven surveillance. We do not just analyze data; we translate rigorous research into decisive health policies and scalable, real‑world public health outcomes.
Clinical Epidemiology • HEOR • Evidence Synthesis • NMA • Public Health Nutrition • Policy Analysis
director@epifractals.com
Key takeaways from the latest framework and what it means for sponsors preparing external control arms.
Best practices for safely integrating LLMs into HEOR workflows while maintaining auditability and scientific rigor.
Insights from recent HTA decisions and how manufacturers can strengthen value communication in high-uncertainty indications.
If you are a professional who finds a natural alignment at the intersection of healthcare data and life sciences, and who values intellectual curiosity, methodological rigor, and a mission-driven mindset, reach out to us.
We should be talking if you have a background in Medicine, MPH, or DPH and a flair for translating complex data into global market access, HTA submissions, and real-world health policy decisions.
Whether you prefer working from our offices, remotely, or alongside our clients, we have a place for you.
Whether you need support on a single study or a strategic evidence partnership across your portfolio, Epifractals brings the right blend of scientific rigor and technological innovation.
Tell us about your evidence needs.