2026 LIFE SCIENCES LANDSCAPE

Real-World Evidence.
Health Economics.
Artificial Intelligence.

Epifractals delivers regulatory-grade RWE, HEOR, and AI solutions that accelerate drug development, secure market access, and improve patient outcomes.

Trusted by leading pharma & biotech teams
REGULATORY IMPACT
78%
of new drug approvals now include RWE components
MARKET ACCESS
3.2×
faster HTA decisions with robust HEOR evidence
AI-ACCELERATED EVIDENCE GENERATION
40-60% reduction
in evidence synthesis timelines
WHO WE ARE

We decode complexity
at the intersection of data, science, and intelligence.

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.

120+
PROJECTS DELIVERED
35
COUNTRIES SUPPORTED
92%
CLIENT RETENTION
THE NEW STANDARD

RWE & HEOR have moved from "Optional"
to "Indispensable".

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.

Real-World Data (RWD)

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.

Real-World Evidence (RWE)

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.

Health Economics & Outcomes Research (HEOR)

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.

Why the urgency has intensified

Regulatory Acceptance

FDA and EMA have formalized expectations and structured programs for RWE use in approvals, label expansions, and post-marketing commitments.

Payer Demands

Payers are raising the bar. Compelling economic and outcomes data is now mandatory for favorable reimbursement and market access decisions globally.

Digital Health Expansion

Wearables, smartphone sensors, and connected devices are generating continuous real-time real-world data at unprecedented scale and granularity.

END-TO-END SUPPORT

Integrated across the entire product lifecycle

From early development through post-launch, Epifractals helps generate the evidence regulators and payers require.

Epidemiology & Burden of Disease

Quantifying incidence, prevalence, and disease trajectories to prioritize indications and inform target product profiles.

Protocol Optimization

Using historical RWD to simulate eligibility criteria, estimate screen failure rates, and anticipate recruitment bottlenecks before trials begin.

Site & Country Selection

Leveraging EHR, claims data, and registries to understand patient populations and optimize study locations for speed and diversity.

THE TRANSFORMATION

AI is fundamentally reshaping
how RWE and HEOR are generated.

Machine learning and generative AI are no longer experimental — they are production-grade tools that dramatically improve speed, depth, and quality of evidence.

Validated workflows
with full audit trails

Unstructured Data → Analyzable Cohorts

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.

Smarter Analytics & Causal Inference

Advanced ML improves confounding adjustment, predictive modeling for treatment response and adverse events, and exploration of heterogeneous treatment effects across complex patient subgroups.

Automated Evidence Synthesis

Generative AI accelerates systematic literature reviews, data extraction, report drafting, and model harmonization — always with rigorous human oversight, validation, and regulatory-grade documentation.

WHERE WE WORK

Industries We Serve

We partner with organizations across the life sciences value chain to generate evidence that drives better decisions and patient outcomes.

Pharmaceutical & Biotech Companies
Medical Devices & Diagnostics
Hospitals & Health Systems
Payers & HTA Bodies
Contract Research Organizations (CROs)
Academic & Research Institutions
Government, Regulatory & Policy Makers
Digital Health & HealthTech Startups
NGOs & Non-Profit Organizations
Alternative Systems of Medicine (AYUSH)
Nutraceutical Companies

Our Trusted Partners

BioQuest INCLEN GRID Council Caring
EXPERTISE

Our Services

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.

1

Evidence Synthesis & Strategic Consulting

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.

Systematic Reviews & Meta-Analysis
Qualitative Evidence Synthesis
Clinical Data Management
Population Health Data Analytics
Real-World Data (RWD) Analysis
Electronic Medical Records (EMR) Analytics
2

Comparative Efficacy & Network Meta-Analysis (NMA)

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.

Efficacy, Safety, & Tolerability Assessments
Certainty of Evidence – GRADE & PRO Assessments
CERQual – Qualitative Evidence Synthesis
3

HTA Dossiers Preparation & Submission

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.

Value Proposition Documents
Reimbursement Support Dossiers
Objection Handler Documents
HTA for New Product Development
Scientific Medical Writing
4

Cost-Impact Analysis & Economic Modelling

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.

Budget Impact Assessment
Predictive & Econometric Modelling
Cost per Outcome Metrics (QALY, cost per responder)
Equity Issues in Economic Modelling
5

Pharmacovigilance & Post-Market Surveillance

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.

Pharmaceutical Products Surveillance
Medical Devices Safety Monitoring
Alternative Health System Interventions
Clinical Trial Coordination
6

Social Impact Assessment

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.

Equity & Ethical Considerations
Risk or Hazards Quantification
Socio-Cultural Acceptability
Environmental Risk Assessment
Population-Based Surveillance
7

Policy Analysis

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.

Decision Support Tools for Policymakers
Integrating HTA during Drug Development
Evidence-Based Decision Making Frameworks
Agent-Based & System Dynamics Simulators
8

HTA for AYUSH (Alternative Systems of Medicines)

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.

Regulatory Documentation for AYUSH
Scientific Validation of AYUSH Interventions
Pharmacovigilance for AYUSH Products
Impact Assessment of AYUSH Products
9

Hands-on Training & Capacity Building on HTA

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.

Target Audiences:
Research Professionals & Medical Students
Healthcare Professionals & Nursing Faculties
Pharmacy Students & Faculties
Institutions and Universities

Ready to Elevate Your Strategy?

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.

THE EPIFRACTALS DIFFERENCE

Foundations of trust in every engagement.

High-stakes decisions require more than data — they require rigor, transparency, and interdisciplinary expertise.

Fit-for-Purpose Data & Design

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.

Robust Data Provenance & Curation

Clear lineage, quality checks, and documentation at every step. We maintain audit-ready records of data origin, transformations, and decisions.

Validation & Sensitivity Analysis

Findings are rigorously tested. We conduct extensive sensitivity analyses and stress-test assumptions to ensure robustness of conclusions.

Interdisciplinary Collaboration

Our teams combine clinical operations expertise, deep RWD methodologists, health economists, and AI/ML specialists — working as one integrated unit.

OUR TEAM

Data‑to‑Impact Health Experts

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.

Dr. Rakesh N Pillai (PhD)
Dr. Rakesh N Pillai (PhD)
Founder Director & Chief Scientific Officer

Clinical Epidemiology • HEOR • Evidence Synthesis • NMA • Public Health Nutrition • Policy Analysis

director@epifractals.com
Mr. Manu Sajevan
Mr. Manu Sajevan
Software Engineer & GIS Specialist
Dr. Bindya Vijayan (MPH)
Dr. Bindya Vijayan (MPH)
Strategic Planning & Public Health
Mr. Vinukumar (MPharm)
Mr. Vinukumar (MPharm)
Operations • Pharmacologist & Clinical Research
Adv. Anand Sankar (LLB)
Adv. Anand Sankar (LLB)
Legal Expert, Company Laws
Sruthi Jayakumar (MPH)
Sruthi Jayakumar (MPH)
Research Associate, Evidence Synthesis
Dr. Roshni Banarji (MPH)
Dr. Roshni Banarji (MPH)
Research Assistant, Evidence Synthesis
Dr. Dhanya B Mohan (MPH)
Dr. Dhanya B Mohan (MPH)
Research Assistant
Aleena Alex
Aleena Alex
Biostatistician, Evidence Synthesis
Aiswarya V (MPH)
Aiswarya V (MPH)
Health Economist
Dr. Nayana Mithunrosh (MPH)
Dr. Nayana Mithunrosh (MPH)
Research Assistant
Dr. Veena Valsan
Dr. Veena Valsan
Research Assistant
Reshma S
Reshma S
Research Intern
INSIGHTS

Latest thinking from our team.

View all articles
RWE • REGULATORY

How FDA’s 2025 RWE Guidance is Reshaping Oncology Submissions

Key takeaways from the latest framework and what it means for sponsors preparing external control arms.

AI • HEOR

Generative AI in Systematic Literature Reviews: Promise vs. Pitfalls

Best practices for safely integrating LLMs into HEOR workflows while maintaining auditability and scientific rigor.

MARKET ACCESS

The New Economics of Rare Disease: What Payers Are Really Asking For

Insights from recent HTA decisions and how manufacturers can strengthen value communication in high-uncertainty indications.

JOIN OUR TEAM

Help us build the future of evidence.

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.

Ready to turn complexity into clarity?

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.

View all capabilities
HEADQUARTERS
LEAP-Centre, Ground Floor, Thejaswani Building,
Technopark Phase-1, Trivandrum-695581, Kerala, India
CAPABILITIES
Regulatory-grade RWE • HEOR • AI/ML • Medical Writing • Market Access