Medical device and IVD CRO services
We can support you in developing a clinical development strategy for your medical device or IVD medical device, as well as conducting pre-market clinical studies and post-market clinical follow-up studies.
CRO services for medical devices and in vitro diagnostic (IVD) medical devices
Let our medical device experts help you with all aspects of your clinical investigations/clinical performance studies from planning, designing and executing to analysis and reporting. In addition, we can support you in building the right clinical development strategy for your medical device or IVD medical device.
Our services include:
- Clinical study start-up, including feasibility assessment and site evaluation
- Clinical project management
- Monitoring and site management
- Clinical investigations and clinical performance studies
- Regulatory submissions to competent authorities and ethics committees, including preparing the submission package
- Medical writing to prepare e.g., protocols/reports
- Data management and biostatistics
- Vigilance
- Outsourcing services for when you need extra resources/interim solutions.
- Quality and regulatory services
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.
Medical device and IVD CRO services
Clinical operations
Our experienced teams can help you plan, design and conduct your clinical studies from start to finish.
Clinical project management
Clinical Project Managers (CPMs) oversee your clinical study to solve challenges and streamline your project.
Vigilance
Vigilance services, including services for medical monitoring, coding of adverse events and safety reporting.
Medical writing
Let our medical writers prepare and update your regulatory and technical documentation quickly and efficiently.
Data management
We support you with robust data management services that ensure the quality of your clinical study data.
Biostatistics
We offer custom solutions for high-quality data analysis to help you design and analyze your clinical study.
Outsourcing solutions
We provide experienced clinical research consultants who integrate seamlessly into your team when you need extra resources.
Types of medical devices and indications
We have deep expertise and extensive experience working with various types of medical devices for a wide range of indications.