A UK Partner for Medical Device Clinical Studies

Enteromed LTD is a UK-based company that specialises in medical device clinical development. Our expert team work collaboratively with your company to design and conduct clinical research trials.

The new Medical device regulations (MDR) and UKCA mark make this a challenging time for medical device manufacturers. We are ready to embrace these challenges with you and discover a way to navigate through well designed and implemented clinical trials successfully.

Our Specialties

Our small experienced team allows us to offer a bespoke service applying all our expertise in conducting medical device clinical studies for both pre-and post-marketing medical studies.

We offer experience in flexible approaches to clinical trial design, incorporating decentralised trials and providing an alternative to the site-anchored systems, which have high drop-out rates.

Patient-centricity is our speciality. Working with patients at an early stage is integral to understanding their needs and, reducing the burden on participation, delivering a better patient experience and retention rate.

You’ll work closely with our team to understand the challenges to overcome to design and deliver a robust, cost-efficient study.

Our Customers' Benefits

  • Operational and Regulatory team with significant experience of UK based medical device studies.
  • Expertise in decentralised trials, including flexible combinations of virtual, home, remote and on-site, to optimise recruitment and retention rates.
  • Risk-based monitoring approach to optimise cost whilst ensuring high-quality data.
  • Small bespoke team with experience in offering value for money through working together to design and deliver an affordable study without those high company CRO costs.
  • Established relationships with the primary and secondary clinical research sites and key opinion leaders to support your medical device trial.

Our Values

  • The needs of every patient matter, and their contribution to the overall design and ongoing improvement of any clinical trial are our goals.
  • We understand you value your product and the importance of working closely together to achieve your goals.
  • Working in a small team enables us to concentrate fully on your trial and treat it as our own.
  • We aspire to be honest and open in everything we do, so you can be confident in putting your trust in us.

Why Choose a Decentralised Clinical Trial?

Decentralisation aims to make clinical trial participation as easy as possible; it enables participants to take part but continue with their normal day-to-day life with the least disruption.

  • 70% of patients live more than two hours from a research site
  • 50% of clinical trials find their participants struggle with poor health and staying enrolled
  • 85% of trials fail to retain enough patients

 

Patients have busy lives, requiring them to attend on-site visits with often extensive travel times and costs can be unreasonable. A decentralised or hybrid clinical trial with a mix of both remote and on-site visits can impact clinical trials significantly:

  • increase recruitment pool and patient diversity
  • patients become more engaged and complete tasks
  • more accurately and honestly
    collect more applicable, diverse and bias-free data by monitoring patients remotely in real-time
  • improved reliability and accuracy of data using technology such as wearables, apps, and smartphones
  • easier standardised reporting and analysis of data

Flexible and fast response to the changing environment with the first interventional virtual trial in the UK

A Clinical Trial to determine the efficacy of the medical device Enterosgel in the treatment of irritable bowel syndrome (RELIEVE IBS-D).

The Challenges

  • Continuation of recruitment during the pandemic via on-site visits
  • Safe participation of patients and healthcare staff

The Solution

  • Developing a hybrid approach, with a combination of on-site visits and remote appointments to allow the continuation of enrolled patients.
  • Setting up a virtual site with a pre-screening questionnaire to continue the safe recruitment of patients throughout the lockdown.

Outcomes / Findings

  • Combination of on-site screening and subsequent remote visits enabled the majority of the 28 sites to continue recruitment and retention of patients during lockdown.
  • Successful recruitment, pre-screening, and enrolment of patients into the virtual site from across the whole of the UK in comparison to the original 28 sites based in England.
  • Close collaboration with the virtual site at the Patient Recruitment Centre Newcastle meant that from initial concept to approval and implementation only took 4 months.
  • Feedback from patients that they found the virtual trial easier to engage with and manage to fit in with their daily life. Other patients were able to participate even though they live too far from any site and would not consider travel due to their health.
  • Delivering study treatment directly to patients' homes enabled an easy switch to remote appointments.
  • Support for sites on coordination of remote visits, supply and collecting of patient questionnaires empowered sites to continue recruitment.
  • E-diaries gave the investigator real-time insight into patients and the ability to identify immediately missing data and improved patient compliance.
  • By implementing these strategies, the recruitment rate was 67% faster.

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