


Healthcare is one of the world's most complex and rapidly evolving ecosystems. Diverse stakeholders, varying clinical practices, reimbursement systems, and policy environments shape healthcare decisions across countries. At the same time, advances in therapeutics, digital health, real-world evidence and artificial intelligence are transforming how healthcare innovations are developed, evaluated, and adopted.
At ETI, we help life sciences, healthcare, and health technology organizations bridge the gap between scientific innovation and real-world patient impact. ETI partners with clients to design, generate, and communicate evidence to enable informed decisions.
Our approach brings together expertise in biostatistics, real-world data and regulatory science to deliver evidence strategies that are scientifically rigorous, strategically relevant and practically executable.

Designed to answer the right questions for the right stakeholders at the right time.
To ensure confidence, reproducibility, and trust in decision-making.
When appropriately quantified and communicated, it enables stronger decisions and more effective risk management.

We deliver evidence master plan, RWE study package, statistical strategy and oversight, integrated summary of evidence and regulatory-ready narratives
We deliver claim–evidence maps, clinical validation strategies, adoption-readiness frameworks and post-market evidence plans.
We deliver practical evidence roadmaps, investor-ready scientific narratives and workshops that help founders understand what must be proven next.
We deliver courses, workshops, and capstone experiences that teach students how innovation moves from product idea to evidence, regulation, adoption, and impact.
We deliver independent scientific review, evidence due diligence, gap assessments and scientific advisory board facilitation.

Priya Kulkarni, Ph.D., is a healthcare leader, statistician and evidence strategist with more than 20 years of experience spanning biopharmaceutical development and digital health. . Her experience spans the full product lifecycle—from discovery and development through regulatory approval, launch, and post-market evidence generation—across multiple therapeutic areas and global markets. Throughout her career, Priya has led evidence strategies for some of the industry's most complex and high-impact programs, including breakthrough oncology therapies, drug-device combinations and AI-enabled digital health technologies. She is recognized for her ability to bridge science, strategy, and decision-making.
Priya has held scientific and leadership roles at Genentech, Roche Information Solutions, Merck and Pfizer, partnering with cross-functional teams across clinical development, regulatory affairs, medical affairs, commercial strategy, and health technology innovation. She holds a Ph.D. and M.A. in Statistics from the University of California, Santa Barbara and an M.Sc. in Applied Statistics and Informatics from the Indian Institute of Technology (IIT), Bombay.
"We have data. We're not sure what evidence we actually need ."
Evidence Master Plan
Fit-for-purpose evidence planning from first study to final submission. A prioritised end-to-end evidence roadmap aligned to your regulatory, payer, and clinical goals.
Statistical strategy & oversight
Endpoint selection, study design input, and DSMB-ready reporting for Phase II–IV programmes.
Integrated summary of evidence
A clear, auditable narrative connecting trial data, RWE, and biomarker findings for regulatory review.
"We're evaluating an asset and need an independent scientific read — quickly."
Evidence due diligence report
Independent assessment of study design quality, data integrity, regulatory exposure, and claimed outcome credibility.
Evidence gap analysis
A clear map of what evidence exists, what is missing, and what it would take to fill the gaps before the next milestone.
Scientific advisory facilitation
Structured KOL or expert advisory sessions that surface the critical questions a deal team needs answered.
"Our team runs studies but doesn't yet think strategically about evidence."
Evidence strategy training
Workshops and mentorship programmes that build strategic thinking alongside technical execution skills.
Statistical methods consultation
Expert input on study design, endpoint selection, adaptive methods, and regulatory-grade analysis approaches.
Publication & communication strategy
Support for translating study results into peer-reviewed publications and stakeholder-ready scientific communications.
"The FDA and CE mark pathways for our SaMD are unclear..."
FDA Pre-submission package
Q-Sub strategy, evidence gap analysis, and meeting preparation to align with FDA before you spend on studies.
Clinical validation plan
Fit-for-purpose study design that satisfies 510(k), De Novo, or PMA requirements without over-engineering.
AI algorithm evidence dossier
Analytical validation, clinical performance evidence, and bias assessment for AI/ML-based medical algorithms.
CE mark technical file support
MDR/IVDR clinical evaluation strategy, PMCF planning, and TÜV-SUD interaction support.
Post-market clinical follow-up plan
PMCF and PASS protocols that satisfy regulators and generate commercially useful long-term safety and outcomes data.
"Our product got approved. Payers still won't cover it."
Reimbursement evidence package
Economic and outcomes evidence structured for payer coverage submissions and HTA review.
"We know real-world evidence matters. We don't know where to start ..."
RWE Study Package
RWE strategy, data source selection, protocols and analysis plan, CRO oversight for claims, EHR, and registry studies .
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