Our expertise
CERC provides expert, evidence-driven strategic guidance across the full product life cycle. We help you define the right clinical pathway, de-risk development, and accelerate time to meaningful evidence and market access.
Who we support
Medtech, biotech, pharma needing either end-to-end study strategy or targeted support on specific milestones.
Engagement options
- Full program strategy: from opportunity assessment to publication plan.
- Targeted modules: pick only what you need (e.g., feasibility, regulatory roadmap, endpoint strategy).
What we deliver
- Clinical development plan aligned with business goals
- Protocol concept / synopsis and endpoint strategy
- Regulatory pathway and pre-submission plan (MDR, FDA, PMDA, GDPR)
- Feasibility & KOL mapping with investigator/site recommendations
- Evidence generation plan including Health Economics Outcomes Research (HEOR) and reimbursement considerations
- Operational model (Core Laboratory, CEC/DSMB, data, safety)
- Budget and timeline modelling with critical path and risk register
- Go/No-Go criteria and decision framework
Our process
- Discover: clarify objectives, constraints, prior evidence.
- Design: define strategy, endpoints, patient population, and geographies.
- Validate: test assumptions with KOLs, potential investigators, and regulators.
- Plan: convert strategy into a practical execution plan and budget.
- Launch support: handover to Trial Management or remain on as advisors.
Why CERC?
- Cardiovascular depth with multidisciplinary experts and global KOL network
- Integrated capabilities (Project Management, Core Laboratory, CEC/DSMB, Data & Stats) for strategy that executes
- Global footprint Europe, Asia, and US partners for worldwide delivery
- Quality and impact with a high level of expertise in the cardiovascular field with more than 20 internationally recognized Key Opinion Leaders.
Typical deliverables
Strategy deck, protocol synopsis, regulatory roadmap, feasibility report, KOL list, risk register, timeline and budget, evidence/HEOR outline, publication plan.
Sample outcomes
- Reduced first-patient-in timeline through optimized site mix
- Accelerated submissions via early regulatory engagement and targeted evidence plans
Ready to refine your study strategy? Contact us to schedule a Strategic Consulting scoping call.
