Unsure which clinical and regulatory pathway is right for your medical device or IVD? LX CRO provides the support you need—from expert consulting through to the planning and conduct of complete clinical investigations.
LX CRO Services
Consulting
Unsure which clinical and regulatory pathway is right for your medical device or IVD? LX CRO provides the support you need—from expert consulting through to the planning and conduct of complete clinical investigations.
We support your access to the European market.
Consulting
Reliable support from device development through post-market activities
Whether your device is in the pre-market or post-market phase, a clinical investigation may be appropriate at various stages of the product lifecycle.
We design and conduct studies in line with the relevant stage of your medical device’s clinical lifecycle, including:
- exploratory studies
- confirmatory studies
- observational studies
We ensure that each study design is precisely aligned with your objectives and the applicable regulatory requirements.
Our core expertise enables us to provide a comprehensive, end-to-end service for all types of clinical investigations, including: First-in-human, feasibility, pivotal, post-market observational, registry, interventional and non-interventional studies.
From planning and conduct through to data analysis, we manage every stage and ensure seamless delivery. Our extensive expertise and strong network help ensure the highest standards of quality and regulatory compliance.
Full-Service CRO
The LX CRO Advantage
Benefit from the combined expertise of our multidisciplinary medical writing team. As a full-service CRO specializing in medical devices and IVDs, we support both individual work packages as well as international, multicenter studies—from project management and design of the study through to the final Clinical Investigation Report.
Tailored Service Options
Let’s discuss your requirements and determine which option is right for you: One of our flexible modular services? Or one of our service packages? The choice is yours.
Transparent Cost Structure
Whether you choose modular services or our comprehensive end-to-end package, you will receive a detailed proposal with a clear and fully transparent cost breakdown.
Your ROI—Predictable and Secure
Our expertise helps you achieve your objectives faster, more efficiently and with greater cost control. We turn complex requirements into clear processes and targeted actions. This makes the return on your investment manageable.
Consulting Enquiry
Dedicated expertise for your clinical study
Have you developed an innovative medical device and are now preparing to bring it to market? We support you across the key processes!
We ensure that all interfaces and responsibilities are clearly defined and properly managed. With us, your projects stays aligned with current clinical and regulatory requirements.
Service Packages
Everything you need—from planning to regulatory approval
Rather than offering isolated services, our tailored packages provide an integrated solution from planning through to regulatory approval. Structured project management, clearly defined processes and evidence-based decision-making ensure efficiency, quality and regulatory compliance throughout your project.