CIMI – CIMI Consulting And Services

Clinical & Medical Strategy Built for Product Advancement

We help medical device and diagnostic companies define clinical strategy and align evidence to support submission and product advancement.

Clinical Study Strategy & Planning

Clinical strategy aligned to product stage, submission goals, and study oversight.

Clinical development roadmap from early feasibility through pivotal studies
Submission-aligned study design and endpoint strategy
Protocol, CRF, and essential document development
Program management and CRO oversight
Data review, monitoring support, and risk mitigation

When product advancement depends on getting clinical strategy right the first time, senior leadership makes the difference.

Medical Insights & Engagement

Strategic medical leadership that aligns clinical evidence with product positioning and credibility.

KOL strategy and advisory board facilitation
Medical input into clinical study endpoints and evidence framing
Scientific narrative and thought leadership support
Investigator engagement guidance
Evidence interpretation for internal alignment

When evidence must resonate with regulators, investigators, and investors, strategic medical guidance is critical.

Strategic clinical and medical leadership. When you need it most.

Let’s discuss how we can support your next phase of development.

Who We Are

CIMI is a clinical strategy and medical affairs consultancy supporting medical device, diagnostics, and biotech organizations navigating complex development decisions. We provide senior level leadership in clinical design, program strategy, and evidence planning.

Our work includes study architecture, submission aligned endpoint strategy, executive program guidance, and sponsor side oversight. We partner with internal teams and external CROs to ensure alignment, inspection readiness, and defensible evidence generation while maintaining appropriate sponsor and CRO responsibilities.

From early feasibility through post market evidence development, CIMI brings disciplined thinking and experienced leadership to clinical programs when clarity and structure matter most.