Medical devices CRO

UK clinical trial set up for Academics, Spin Outs and Start Ups.

Partner with us to expedite your medical device clinical investigation

We work collaboratively with our Sponsors to effectively manage the clinical trial process for Medical Devices Class I to III. By developing a robust clinical investigation plan (protocol) and adopting a quality-first approach, we ensure the right GCP (ISO 14155), regulatory and legal boxes are ticked from day 1, enabling fast setup and timelines.

Your assigned project team has a best-in-class reputation in delivering successful academic and commercial trials (including ATMP and combination studies) across multiple therapeutic areas with particular experience in Hepatology, Ophthalmology, Cardiology, Infectious Diseases, ENT, Endocrinology, Oncology, and Surgery/Prosthetics.

Tailored services to meet your budget and resource needs

Free initial CEO consultation and guidance [New]
Grant application support
Clinical investigation plan (Protocol) development
UK & EU device regulatory approvals
Project and study management
Site setup and Initiation
Monitoring (risked based) & site management
Device safety management & reporting
Statistics & data management
ISO 9001:2015 certified Quality Management System
ATMP and rare disease study experience

In collaboration with our dedicated partners, we operate in countries outside the UK and are happy to discuss global requirements.

"PHARMExcel is by far the most effective CRO I have worked with in achieving targets and the easiest to work with. They have a thorough understanding of the regulatory requirements for managing GCP-compliant clinical trials. I have no hesitation in recommending them as a CRO."

Dr Kim Orchard, Consultant Haematologist, University Hospital Southampton

"The most collaborative CRO I've worked with. PHARMExcel bothered to know us as a client and understands our studies inside out, making it an efficient and friendly partnership."

Prof Mark Lowdell, CSO, INmune Bio Inc.

Not sure how to take your innovation to the clinical stage?

Take advantage of our no-fee consultation*

Our CEO, Yvanne Enever, is passionate about supporting academic investigators and university spin-outs to further their research and is delighted to offer a no-fee consultation to answer initial questions such as:

How do I determine the right classification and category of my medical device?
What UK and EU regulatory frameworks should I follow?
What’s the guidance on recent legislative changes?
Why is an ISO 13485 Quality Management System important?
What is the UK MHRA submission and assessment process for medical device investigations?
How do I obtain a UKCA or EU CE marking?
What is a Conformity Assessment?
What post-market surveillance requirements should I be aware of?

Book a free consultation

* Our ‘no-fee’ consultation allows you to discover the best route to take for your medical device trial. In just a single 30-minute telephone call we’ll guide you in taking the correct regulatory steps relevant to your chosen commercial pathway.

"PHARMExcel’s passion for their projects, the flexibility shown by the team, combined with direct access to the CEO, sets PHARMExcel apart from other CROs."

Daniel Green, CEO and Sponsor, Yaqrit

Why do sponsors and sites enjoy working with us?

You get a personal approach – our clients get direct access to our CEO & Founder, Yvanne Enever, whose 30+ years’ experience in the research industry, particularly in the academic sector, brings value-add to your project.

Extensive knowledge of UK & EU regulatory framework
Gain high-level compliance expertise and ensure your trial data conforms to the Medical Device Regulatory (MDR) requirements, avoiding delays to your trial.

Collaboration and transparency
Working collaboratively as an extension of your team, we engage quickly to understand your requirements and guide your clinical trial through the best pathway.

The PHARMExcel team

Agile & solution-focussed
As a small to medium size CRO we can act fast without excessive bureaucracy and genuinely dedicate ourselves to the shared success of your study.
Quality Assurance
Get an integrated Quality Management System with a GCP and ISO-trained clinical ops team to ensure quality and compliance at every step of your trial.
Flexible & transparent costings
Our ‘mix and match’ service model allows our Sponsors to benefit from a beposke service. Transparency is important to us; our detailed costing breakdown ensures expectations and deliverables are agreed upon by both sides from the outset.

We're focused on getting your trial through the regulation process

Here are some success cases

ONCOLOGY Device-ATMP

A UK multi-site, open-label study of intraperitoneal INKMUNE in patients with relapsed platinum resistant, platinum refractory or platinum intolerant ovarian cancer.

Sponsor – INmuneBio Inc

HEPATOLOGY Class III -Interventional

Multi-centre, open, randomised, and controlled trial of Alfapump system conducted in patients diagnosed with refractory ascites.

Sponsor – Sequana Medical

ENT Class I (CE marked)

Prospective, multi-site study utilising a CE marked Cleara Talk nasal device in patients as prosthetic treatment option for nasal speech.

Sponsor – Converse Healthcare

HEPATOLOGY Class III

A first-in-human, multi-center, randomised controlled study, to evaluate the safety and performance of the DIALIVE liver dialysis device in alcohol-related cirrhosis patients with acute on chronic liver failure versus standard of care.

Sponsor – Yaqrit

SURGERY/PROSTHETICS Class I (prototype)

A clinical investigation to assess the clinical and non-clinical outcomes of an adaptive prosthetic liner (prototype) vs a standard prosthetic liner in transtibial amputee patients.

Sponsor – Imperial College London

INFECTIOUS DISEASES IMP-Device

Bovactant (Alveofact®) – bovine lung surfactant/AeroFact-COVID™ Drug Delivery System (AF-COVID)

A clinical trial of nebulized surfactant for the treatment of severe COVID-19 in adults (COVSurf)

Sponsor – NHS University Hospital Southampton