Strategic Clinical Oversight for Medical Device Innovation
UK Hospitals
Hospital Staff Relationships
Years of Experience
While our capabilities support a broad range of medicine, we have developed a specific proficiency in the regulatory and clinical pathways required for medical technology. Operating as a global CRO, we provide either targeted assistance for specific study milestones or complete, end-to-end management for device trials.
We partner with medtech start-ups, established manufacturers, and academic innovators to deliver studies that are compliant with international standards, operationally sound, and focused on demonstrating both safety and clinical performance.
Navigating the Nuances of Medtech Trials
Clinical research in the device sector is distinct from pharmaceutical development, often requiring a focus on technical reliability, user interface, and long-term durability.
Whether the study involves a Class I diagnostic tool or a high-risk Class III implantable device, the framework must be meticulously designed to meet the requirements of the Medical Device Regulation (MDR) and ISO 14155.
We design Clinical Investigation Plans (CIPs) that balance technical ambition with the practicalities of clinical use, ensuring that the data generated is sufficient for CE marking, UKCA marking, and global regulatory submissions.
Targeted Site Selection and Technical Infrastructure
Selecting the right environment for a device trial requires a deep understanding of a site’s technical capabilities and administrative agility.
Through our deep-rooted experience with UK and European sites, we identify units that possess the specific support and dedicated clinical space needed to host device-led research.
Our advantage comes from years of direct, on-the-ground collaboration. We know which sites can navigate the unique contracting and indemnity hurdles associated with new hardware and which units have the internal IT infrastructure to support data-heavy diagnostic platforms.
By working with us, you gain access to this local intelligence, ensuring your trial is placed in environments where the clinical team is technically equipped and operationally ready to adopt your innovation.
Technical Integration and Human Factors
Device trials depend on the quality of the interaction between the user and the technology. We specialise in managing the high-intensity requirements of device research, including human factors studies, investigator training, and real-world performance tracking.
We act as the vital link between the sponsor, the clinical site, and the regulatory bodies, ensuring that every procedure is performed according to the relevant local regulations and that technical data is captured with absolute precision.
Frequently Asked Questions
What range of services do you provide for medical device trials?
We offer a full-service model including clinical evaluation plans (CEPs), CIPs and regulatory submissions through to site management, monitoring, post-market clinical follow-up, Clinical Evaluation Reports (CERs) and technical file preparation to support global market access.
How do you help sponsors select the right sites for devices?
Because we know the UK and European sites so intimately, we guide sponsors toward locations that have the specific technical infrastructure required for their hardware. We identify sites that have the capacity to adopt new technology rapidly and a proven track record in medical device investigations.
Can you handle the regulatory hurdles for high-risk Class III devices?
Yes. Our team is well-versed in the stringent requirements of the MDR and ISO 14155. We manage the complex clinical investigation applications required for implantables and other high-risk devices, ensuring all safety reporting and performance monitoring meet international standards.
How do you manage the technical training required for a device trial?
We coordinate comprehensive investigator training programmes to ensure the device is used consistently across all global sites. This includes managing the logistics of training materials, proctoring initial procedures, and providing ongoing technical support to site staff to maintain data integrity.
What makes your project teams different from a large, generic CRO?
Continuity and technical focus. You won’t deal with a revolving door of staff who don't understand your hardware. Our senior experts stay with your project from the initial risk assessment through to final reporting, ensuring that the technical nuances of your device are understood by everyone involved.
Do you support medtech companies with pilot and feasibility studies?
Absolutely. We have extensive experience with early-phase "First-in-Human" device trials and feasibility studies. We provide the agile framework needed to test new concepts, gather early performance data, and refine the technology before moving into larger pivotal trials.
Case Study: Pilot Safety Evaluation of a Novel Extracorporeal Device
As the partner for a complex pilot study, we managed the clinical evaluation of a first-in-kind biocompatible coating designed to reduce inflammatory complications in patients undergoing haemodialysis.
The project required the seamless integration of a new medical device into established extracorporeal circuits within busy renal units.
We oversaw the entire clinical lifecycle, including the complex regulatory submissions required for an investigational device used in an acute clinical setting.
By leveraging our deep knowledge of renal centres, we selected sites with the specific technical expertise to manage the device's integration while maintaining stringent safety monitoring for the patient cohort.
Our senior-led project team ensured that safety endpoints and technical performance data were captured with total precision, providing the sponsor with the robust evidence needed to support the device’s continued clinical development and future regulatory pathway.