Clinical Strategy and Study design for Medical Device and IVDs
What We Offer:
Clinical Development Planning
We help you define a clinical strategy for your device or portfolio – tailored to your claims, risk class, and intended markets. This includes input into Clinical Evaluation Plans, Performance Evaluation Plans, and long-term post-market planning.
Study Design & Study Plan Development
We lead the design of clinical or performance studies – ensuring that your study plan (CIP for medical devices or CPSP for IVDs) is scientifically sound, feasible to execute, and aligned with regulatory expectations.
Our methodology ensures that endpoints are clinically meaningful, data collection is structured for analysis, and the study contributes to your overall clinical evidence strategy.
Cross-functional Design Workflow
Our study design process is collaborative by default.
We bring together a structured design group including:
- Senior clinical consultant (design lead)
- Biostatistician
- Clinical Data manager
- Safety manager
- Sponsor/manufacturer representative
- Medical advisor
This team ensures the study is designed with input from all critical domains – from methodology to execution and reporting.
Integrated Risk Management
Every strategy and design is assessed through a risk-based lens. We apply structured risk management not only at study level, but across the broader clinical project– in line with ISO 14971 and good clinical practice principles.
Why It Matters
A well-designed study starts with a well-founded strategy. We help you avoid costly missteps by planning smart, designing realistically, and generating evidence that holds up – both scientifically and regulatorily.
Our approach is collaborative, quality-driven, and grounded in real-world constraints – tailored to the reality of your product.
Let’s talk about how we can support your clinical strategy or upcoming study.