Clinical Strategy & Study Design
Regulatory approval requires clinical data — but resources are finite. I help you design a clinical evidence strategy that satisfies regulatory requirements within your actual budget and timeline.
The Problem
A single study with 50 patients cannot simultaneously power a primary efficacy endpoint, a non-inferiority comparison, health economics outcomes, and three secondary objectives. Yet this is exactly what many clinical development plans attempt — leading to underpowered studies, regulatory delays, and wasted resources.
The root cause is usually a disconnect between what the business wants to claim, what the study can realistically demonstrate, and what the regulatory pathway requires. These conflicts need to be identified and resolved before the first patient is enrolled — not during the submission review.
My Approach
I work at the intersection of clinical science, biostatistics, and regulatory strategy. Every engagement starts with one question: what do you need to prove, and what can your data realistically support?
From there, I develop a clinical evidence strategy that aligns your study design with your regulatory pathway, your budget constraints, and the current state of the art in your therapeutic area. The result is a protocol that is scientifically sound, statistically powered, and regulatory-ready.
Service Catalog
Clinical Research Strategy
Strategic assessment of your clinical evidence needs: what questions must be answered for regulatory approval, what data already exists, and what studies are needed. I map your claims to the evidence required to support them and identify the most efficient path to market — whether that involves a single pivotal trial, a literature-based approach, or a phased evidence generation plan.
Study Design & Protocol Development
Full protocol development compliant with ISO 14155, from study rationale and objectives through endpoint selection, inclusion/exclusion criteria, visit schedules, and data collection plans. I design studies that are operationally feasible, statistically sound, and aligned with your regulatory submission strategy. Deliverables include the Clinical Investigation Plan (CIP), Investigator's Brochure (IB), and a Statistical Analysis Plan (SAP).
Sample Size Estimation & Statistical Analysis Plans
Rigorous sample size calculations based on your primary endpoint, expected effect size, and regulatory requirements. I develop complete Statistical Analysis Plans (SAPs) covering primary and secondary analyses, interim analyses if applicable, handling of missing data, sensitivity analyses, and subgroup analyses. All calculations are performed in R with fully documented, reproducible code.
Systematic Literature Reviews
Comprehensive, protocol-driven literature searches to establish the current state of the art for your device and indication. Conducted according to PRISMA guidelines with documented search strategies, screening criteria, and quality assessment. These reviews serve as the foundation for clinical evaluation reports, study design justification, and regulatory submissions.
Independent Statistical Analysis
End-to-end statistical analysis of clinical study data using R/RStudio. From data cleaning and exploratory analysis through confirmatory hypothesis testing and final study reports. All analyses are fully reproducible with documented code, validated against the SAP, and presented in publication-ready tables and figures.
Regulatory Framework
All pre-market services are delivered in compliance with the applicable regulatory and normative framework:
- EU Medical Device Regulation (EU) 2017/745 (MDR)
- ISO 14155 — Clinical investigation of medical devices for human subjects
- 21 CFR 812 — Investigational Device Exemptions (FDA)
- ICH E6(R2) — Good Clinical Practice
- ICH E9 — Statistical Principles for Clinical Trials
- MEDDEV 2.7/1 Rev. 4 — Clinical evaluation guidance
- MDCG guidance documents (as applicable)
Need a clinical evidence strategy for your device?
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