Achieve Your Business Goals with ETI

"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.

Publication & Communication Strategy

Support for translating study results into peer-reviewed publications and stakeholder-ready scientific communications.

"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 answere

"The FDA and CE mark pathways for our SaMD are unclear..." 

FDA Pre-submission Package

Q-Sub evidence strategy, evidence gap analysis, and meeting preparation to align with FDA before you spend on studies.

CE Mark Technical File Support

MDR/IVDR clinical evaluation strategy, PMCF planning, and TÜV-SUD interaction support.

Clinical Validation Plan

Fit-for-purpose study design that satisfies 510(k), De Novo, or PMA requirements without over-engineering.

Post-market Clinical Follow-up Plan

PMCF and PASS protocols that satisfy regulators and generate commercially useful long-term safety and outcomes data.  

AI Algorithm Evidence Dossier

Analytical validation, clinical performance evidence, and bias assessment for AI/ML-based medical algorithms.

 "Our team runs studies but doesn't yet think strategically about evidence."

Trainings

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.

"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 .