Do you require a clinical investigation for your medical device? From study planning and conduct through to data analysis, we manage every stage and ensure seamless delivery under controlled conditions. We support your access to the European market.
LX CRO Services
Clinical Investigations
Do you require a clinical investigation for your medical device? From study planning and conduct through to data analysis, we manage every stage and ensure seamless delivery under controlled conditions.
We support your access to the European market.
Clinical Investigations
Product Lifecycle
We design and deliver clinical studies in line with the relevant stage of your medical device lifecycle—from development through to post-market activities.
- First-in-human studies
- Exploratory feasibility studies
- Confirmatory pre-market clinical investigations
- Interventional and non-interventional studies
- Observational PMCF studies
- Registry studies
- Performance studies
We ensure that each study design is precisely aligned with your objectives and requirements, and takes into account the applicable regulatory framework – including Articles 61–82 of Regulation (EU) 2017/745 on medical devices (MDR), relevant national legislation, and ISO 14155 standard.
Services
Clinical Investigations
What type of clinical study does my product require—or is a clinical study required at all? Which stage of the clinical product lifecycle has my device reached? Which investigational sites and partners are suitable? How much clinical data needs to be generated?
We help you answer these and other key questions and support you across all relevant areas.
Full-Service CRO
Your Advantage with LX CRO
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 good cost control. We turn complex requirements into clear processes and targeted actions. This makes the return on your investment manageable.
Clinical Investigation 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 throughout the key clinical and regulatory 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
From Planning to CE Marking
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 every stage of your clinical investigation.