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Clinical Research Organisation

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A UK Partner for Medical Device Clinical Studies

[/vc_column_text][vc_column_text css_animation=”slideInLeft”]EnteroMed is a small 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 successfully navigate, through well designed and implemented clinical trials.[/vc_column_text][vc_empty_space height=”28px”][/vc_column][vc_column width=”1/2″][vc_empty_space height=”28px”][vc_single_image image=”275502″ img_size=”full” css_animation=”fadeIn”][vc_empty_space height=”28px”][/vc_column][/vc_row][vc_row full_width=”stretch_row” content_placement=”middle” et_uniqid=”et_custom_uniqid_602bfc68a7138″ css=”.vc_custom_1614787226631{background-color: #f2f6ff !important;}” _et_uniqid=”et_custom_uniqid_new_603fb293da0d9″][vc_column width=”1/2″][vc_empty_space height=”28px”][mpc_image image=”275661″ image_size=”full” force_fullwidth=”true” image_opacity=”100″ image_inner_border_gap=”0″ effect=”none” image_hover_opacity=”100″ animation_in_type=”transition.slideLeftIn” animation_in_offset=”100″ animation_in_duration=”700″ animation_in_delay=”650″][vc_empty_space height=”28px”][/vc_column][vc_column css_animation=”fadeIn” width=”1/2″ et_uniqid=”et_custom_uniqid_602c5dd05389c” _et_uniqid=”et_custom_uniqid_new_603fabb0b9525″][vc_empty_space height=”28px”][vc_column_text css_animation=”fadeIn”]

Our Specialties

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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 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

[/vc_column_text][vc_empty_space height=”28px”][/vc_column][/vc_row][vc_row full_width=”stretch_row” content_placement=”middle” et_uniqid=”et_custom_uniqid_602c2e826af4c” _et_uniqid=”et_custom_uniqid_new_604b69419cfe1″ css=”.vc_custom_1615554906159{background: #edf2f6 url(https://enteromed.co.uk/wp-content/uploads/2021/02/an-bg05.png?id=275483) !important;}”][vc_column width=”1/2″ et_uniqid=”et_custom_uniqid_602c616ae6b05″ _et_uniqid=”et_custom_uniqid_new_603facacd5205″][vc_empty_space height=”28px”][vc_column_text css_animation=”fadeIn”]

Our Customers Benefit From:

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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 of offering value for money, through working together to design and deliver an affordable study without those large company CRO costs.
Established relationships with primary, secondary clinical research sites, key opinion leaders to support your medical device trial.

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Our Values

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The needs of every patient matters and their contribution to the overall design and ongoing improvement of any clinical trial is our goal

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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

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Why Choose a Decentralised Clinical Trial?

[/vc_column_text][vc_zigzag align=”left” el_width=”20″][vc_empty_space height=”28px”][vc_column_text css_animation=”fadeIn”]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

[/vc_column_text][vc_empty_space height=”28px”][/vc_column][/vc_row][vc_row full_width=”stretch_row” content_placement=”middle” et_uniqid=”et_custom_uniqid_602c2e826af4c” _et_uniqid=”et_custom_uniqid_new_603fc0ea29421″ css=”.vc_custom_1614790898975{background-image: url(https://enteromed.co.uk/wp-content/uploads/2021/02/an-bg05.png?id=275483) !important;}”][vc_column width=”1/2″ et_uniqid=”et_custom_uniqid_602c616ae6b05″ _et_uniqid=”et_custom_uniqid_new_603fc0f56486e”][vc_empty_space height=”28px”][vc_column_text]

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

[/vc_column_text][vc_zigzag align=”left” el_width=”20″][vc_empty_space height=”28px”][vc_tta_accordion style=”modern” shape=”round” color=”white” active_section=”1″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”Case Study” tab_id=”1614720024039-d77dec66-a96f”][vc_column_text]A Clinical Trial to determine the efficacy of the medical device Enterosgel in the treatment of irritable bowel syndrome (RELIEVE IBS-D)[/vc_column_text][/vc_tta_section][vc_tta_section title=”The Challenges” tab_id=”1614720024100-ba16d3b1-f351″][vc_column_text]Continuation of recruitment during the pandemic via on-site visits

Safe participation of patients and healthcare staff[/vc_column_text][/vc_tta_section][vc_tta_section title=”The Solution” tab_id=”1614722209166-ce7f4a70-aaa7″][vc_column_text]Developing a hybrid approach, with a combination of on-site visits and remote appointments to allow continuation of enrolled patients

Setting up a virtual site with pre-screening questionnaire to continue the safe recruitment of patients throughout lockdown[/vc_column_text][/vc_tta_section][vc_tta_section title=”Outcomes / Findings” tab_id=”1614722252168-4bb3329b-3ae2″][vc_column_text]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 home 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, recruitment rate was 67% faster[/vc_column_text][/vc_tta_section][/vc_tta_accordion][vc_empty_space height=”28px”][/vc_column][vc_column width=”1/2″][vc_empty_space height=”28px”][mpc_image image=”275677″ image_size=”full” force_fullwidth=”true” image_opacity=”100″ image_inner_border_gap=”0″ effect=”none” image_hover_opacity=”100″ animation_in_type=”transition.slideLeftIn” animation_in_offset=”100″ animation_in_duration=”700″ animation_in_delay=”650″][vc_empty_space height=”28px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text css_animation=”fadeIn”]

In The News

[/vc_column_text][vc_zigzag el_width=”20″][/vc_column][/vc_row][vc_row full_width=”stretch_row” et_uniqid=”et_custom_uniqid_603ec745731e1″ css=”.vc_custom_1614727136723{background-image: url(https://enteromed.co.uk/wp-content/uploads/2021/03/an-bg06.png?id=275623) !important;}” _et_uniqid=”et_custom_uniqid_new_603ec7bfce7c3″][vc_column width=”1/5″][team_member type=”1″ img_effect=”2″ text_align=”center” target=”_blank” overlay_bg=”#ffffff” name=”New Government Guidance “Saving and improving lives: the future of UK clinical research delivery”” position=”23 March 2021″ img=”275790″]Enteromed and the virtual trial are mentioned in the section Improving access and building resilience: RELIEVE IBS-D

Enteromed and the virtual trial are mentioned in the section Improving access and building resilience: RELIEVE IBS-D[/team_member][/vc_column][vc_column width=”1/5″][team_member type=”1″ img_effect=”2″ text_align=”center” target=”_blank” name=”NIHR Clinical Research Network Virtual Event for the Life Sciences Industry” position=”03 March 2021″ img=”275614″]Carol Howell the Research Director at Enteromed will present the virtual RELIEVE IBS-D trial at an interactive session of the NIHR-Virtual Industry Event on 3^rd March 2021. This event provides an opportunity to discuss the latest developments and opportunities in the UK clinical research environment. Register to attend at……..

Carol Howell the Research Director at Enteromed will present the virtual RELIEVE IBS-D trial at an interactive session of the NIHR-Virtual Industry Event[/team_member][/vc_column][vc_column width=”1/5″][team_member type=”1″ img_effect=”2″ text_align=”center” target=”_blank” name=”PharmafieldPf Awards 2021″ position=”2021″ img=”275774″]Enteromed and the Patient Recruitment Centre Newcastle are shortlisted for the Team Innovation Award at Pharmafield Pf Awards 2021.

Enteromed and the Patient Recruitment Centre Newcastle are shortlisted for the Team Innovation Award at Pharmafield Pf Awards 2021.[/team_member][/vc_column][vc_column width=”1/5″][team_member type=”1″ img_effect=”2″ text_align=”center” target=”_blank” name=”Lord Bethall Minister of Innovation recently tweeted” position=”31 January 2021″ img=”275624″ twitter=”JimBethell”]“I am passionate about taking UK clinical trials to the next level. To offer patients best therapies as quickly as possible.” Our RELIEVE IBS-D trial is mentioned

“I am passionate about taking UK clinical trials to the next level. To offer patients best therapies as quickly as possible.” Our RELIEVE IBS-D trial is mentioned..[/team_member][/vc_column][vc_column width=”1/5″][team_member type=”1″ img_effect=”2″ text_align=”center” target=”_blank” name=”Virtual trial recruits 67% faster led by NIHR Patient Recruitment Centre” position=”25 November 2020″ img=”275627″]Virtual trial recruits 67% faster led by NIHR Patient Recruitment Centre in Newcastle in collaboration with Enteromed.

Virtual trial recruits 67% faster led by NIHR Patient Recruitment Centre in Newcastle in collaboration with Enteromed.[/team_member][/vc_column][/vc_row][vc_row full_width=”stretch_row” content_placement=”bottom” et_uniqid=”et_custom_uniqid_603f9397bce83″ _et_uniqid=”et_custom_uniqid_new_60400771773ac” css=”.vc_custom_1614808953541{background-image: url(https://enteromed.co.uk/wp-content/uploads/2021/02/an-bg02.png?id=275482) !important;}”][vc_column width=”1/2″][vc_single_image image=”275695″ img_size=”full” css_animation=”left-to-right”][/vc_column][vc_column width=”1/2″][vc_cta h2=”The future of clinical trials is a bespoke service with a small team that will work exclusively with you to cater to your device and patient needs.” h4=”We’re always available to help” style=”outline” css_animation=”right-to-left”]To learn more about EnteroMed’s Clinical Trial services please contact:

Carol Howell

Research Director

research@enteromed.co.uk[/vc_cta][/vc_column][/vc_row][vc_row css_animation=”bottom-to-top” et_uniqid=”et_custom_uniqid_60400d9f46d05″ _et_uniqid=”et_custom_uniqid_new_60400da0e8532″][vc_column][mpc_icon_column background_color=”#ffffff” border_css=”border-width:3px;border-color:#f0f0f0;border-style:solid;border-radius:6px;” padding_divider=”true” padding_css=”padding-top:10px;padding-right:20px;padding-bottom:20px;padding-left:20px;” margin_css=”margin:0px;” title=”Participate in a clinical trial” title_margin_divider=”true” content_margin_divider=”true” hover_background_type=”gradient” hover_background_gradient=”#1d119c||#08c6ea||0;100||145||linear” hover_border_divider=”true” hover_border_css=”border-radius:6px;” hover_title_color=”#f7f7f7″ hover_content_color=”#ffffff” mpc_icon__border_divider=”true” mpc_icon__padding_divider=”true” mpc_icon__margin_divider=”true” mpc_icon__hover_border_divider=”true” mpc_icon__mpc_tooltip__border_divider=”true” mpc_icon__mpc_tooltip__border_css=”border-color:undefined;border-style:undefined;” mpc_icon__mpc_tooltip__padding_divider=”true” mpc_divider__content_border_divider=”true” mpc_divider__content_padding_divider=”true” mpc_divider__padding_divider=”true” mpc_divider__margin_divider=”true”]Interested in learning more about how to volunteer in a clinical trial? Find information about participating in a clinical study here.[/mpc_icon_column][/vc_column][/vc_row][vc_row full_width=”stretch_row” css_animation=”bottom-to-top” et_uniqid=”et_custom_uniqid_603fa60168497″ css=”.vc_custom_1614810552619{margin-bottom: -35px !important;background-image: url(https://enteromed.co.uk/wp-content/uploads/2021/03/footer-bg.png?id=275651) !important;}” _et_uniqid=”et_custom_uniqid_new_60400dae78c3d”][vc_column width=”1/3″][mpc_icon_column url=”url:https%3A%2F%2Fredcap.link%2Fnhs-relieve” background_type=”gradient” background_gradient=”#1d119c||#08c6ea||0;100||145||linear” border_css=”border-width:3px;border-color:#f0f0f0;border-style:solid;border-radius:6px;” padding_divider=”true” padding_css=”padding-top:10px;padding-right:20px;padding-bottom:20px;padding-left:20px;” margin_css=”margin:0px;” title_font_color=”#ffffff” title=”Join the RELIEVE IBS-D Trial” title_margin_divider=”true” content_margin_divider=”true” hover_background_color=”#ffffff” hover_border_css=”border-width:3px;border-color:#f0f0f0;border-radius:6px;” hover_title_color=”#01438f” hover_content_color=”#ffffff” mpc_icon__border_divider=”true” mpc_icon__padding_divider=”true” mpc_icon__margin_divider=”true” mpc_icon__hover_border_divider=”true” mpc_icon__mpc_tooltip__border_divider=”true” mpc_icon__mpc_tooltip__border_css=”border-color:undefined;border-style:undefined;” mpc_icon__mpc_tooltip__padding_divider=”true” mpc_divider__content_border_divider=”true” mpc_divider__content_padding_divider=”true” mpc_divider__padding_divider=”true” mpc_divider__margin_divider=”true”][/mpc_icon_column][vc_empty_space height=”50″][/vc_column][vc_column width=”1/3″][mpc_icon_column url=”url:https%3A%2F%2Fbepartofresearch.nihr.ac.uk%2F” background_color=”#ffffff” border_css=”border-width:3px;border-color:#f0f0f0;border-style:solid;border-radius:6px;” padding_divider=”true” padding_css=”padding-top:10px;padding-right:20px;padding-bottom:20px;padding-left:20px;” margin_css=”margin:0px;” title=”National Institute for Health Research (NIHR) Be Part of Research” title_margin_divider=”true” content_margin_divider=”true” hover_background_type=”gradient” hover_background_gradient=”#1d119c||#08c6ea||0;100||145||linear” hover_border_divider=”true” hover_border_css=”border-radius:6px;” hover_title_color=”#f7f7f7″ hover_content_color=”#ffffff” mpc_icon__border_divider=”true” mpc_icon__padding_divider=”true” mpc_icon__margin_divider=”true” mpc_icon__hover_border_divider=”true” mpc_icon__mpc_tooltip__border_divider=”true” mpc_icon__mpc_tooltip__border_css=”border-color:undefined;border-style:undefined;” mpc_icon__mpc_tooltip__padding_divider=”true” mpc_divider__content_border_divider=”true” mpc_divider__content_padding_divider=”true” mpc_divider__padding_divider=”true” mpc_divider__margin_divider=”true”][/mpc_icon_column][vc_empty_space height=”50″][/vc_column][vc_column width=”1/3″][mpc_icon_column url=”url:https%3A%2F%2Fnewcastlejro.com%2Ftake-part%2Fresearchplusme%2F” background_color=”#ffffff” border_css=”border-width:3px;border-color:#f0f0f0;border-style:solid;border-radius:6px;” padding_divider=”true” padding_css=”padding-top:10px;padding-right:20px;padding-bottom:20px;padding-left:20px;” margin_css=”margin:0px;” title=”Research+Me” title_margin_divider=”true” content_margin_divider=”true” hover_background_type=”gradient” hover_background_gradient=”#1d119c||#08c6ea||0;100||145||linear” hover_border_divider=”true” hover_border_css=”border-radius:6px;” hover_title_color=”#f7f7f7″ hover_content_color=”#ffffff” mpc_icon__border_divider=”true” mpc_icon__padding_divider=”true” mpc_icon__margin_divider=”true” mpc_icon__hover_border_divider=”true” mpc_icon__mpc_tooltip__border_divider=”true” mpc_icon__mpc_tooltip__border_css=”border-color:undefined;border-style:undefined;” mpc_icon__mpc_tooltip__padding_divider=”true” mpc_divider__content_border_divider=”true” mpc_divider__content_padding_divider=”true” mpc_divider__padding_divider=”true” mpc_divider__margin_divider=”true”][/mpc_icon_column][vc_empty_space height=”50″][/vc_column][/vc_row]