We conduct full-scope clinical studies pre- and post-market across a variety of therapeutic areas. As a leading contract research organization, we specialize in providing comprehensive services supporting the successful design, development, execution, and management of clinical trials. 

Post-market clinical Follow-Up (PMCF) surveys have become essential for medical device manufacturers in an increasingly regulated medical world. They provide insights into the performance and safety of devices in real-world settings and ensure compliance with regulatory requirements such as the EU MDR and FDA.

We design and execute IVD clinical performance studies to demonstrate the accuracy, reliability, and clinical value of your diagnostic device. For stand-alone IVD products and for companion diagnostics (CDx) connected to a drug trial. Our team ensures your study generates robust data to support regulatory approval and long-term success.

We deliver clinical strategy support to help you define the most effective path from concept to market. Our team partners with you to design innovative, scalable clinical plans that align with regulatory requirements, accelerate timelines, and maximize the value of your clinical data.

Clear, accurate, and compliant clinical evaluations are essential to get your medical device approved. We specialize in medical writing services that combine scientific precision with regulatory expertise, with a very high success rate in achieving regulatory approval in the EU.

We provide clinical interim support in every aspect of clinical operations during periods of transition or staffing gaps. Whether you need short-term leadership, clinical monitoring, or project coordination, our experts step in quickly to maintain momentum and ensure effective continuation of clinical operations.

We specialize in clinical audits designed for medical device trials. Our tailored services help sponsors maintain control, enhance quality, and prepare confidently for regulatory submissions and inspections.

We specialize in equipping clinical teams with the skills and insights they need to navigate the complexities of clinical trials while maintaining regulatory compliance.