[vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1655529302573{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/3a801cec06685b436334b9e658635487-2.jpeg?id=8948) !important;}”][vc_column][vc_custom_heading text=”Another Way to Market Access” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_custom_heading text=”Clinical Sites Support” font_container=”tag:h2|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”top” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652437452304{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/Thiết-kế-chưa-có-tên-1.png?id=8951) !important;}”][vc_column width=”5/12″][/vc_column][vc_column width=”7/12″][vc_custom_heading text=”Partnerships with Government Hospitals” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]We have established unique collaborations with local hospitals and this is necessary to enable MedTech SMEs from other countries to perform clinical investigation and trials, usability studies, feasibility trials on local intended patients[/vc_column_text][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652435500857{padding-right: 8% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/Thiết-kế-chưa-có-tên-3.png?id=8953) !important;}”][vc_column width=”1/3″][/vc_column][vc_column width=”2/3″][vc_custom_heading text=”Supporting Innovation Management and Clinical Advances” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]We mitigate client risk in clinical trials by evaluating the market potential and suitability of clients’ products, assessing if the necessary requirements have been met. Our team of engineers can offer objective opinions on the industrial design for prototyping purposes.

We understand the various challenges faced by the companies preparing for clinical trials because we have the experience to consult and support companies in the earlier stages of development. We can become your clinical site sponsor and review your clinical investigation protocol to achieve the ultimate aim.[/vc_column_text][/vc_column][/vc_row][vc_row equal_height=”yes” disable_element=”yes” leaf_row_scheme=”0″][vc_column width=”1/2″][vc_empty_space height=”50px”][vc_column_text]We have existing partnerships with government hospitals. This gives us access to hundreds of potential subjects, Principal Investigators, and academic research resources.

Collaborative efforts with these hospitals are necessary to enable MedTech SMEs from other countries to perform clinical investigation and trials, usability studies, feasibility trials on local intended patients

We are able be your clinical site sponsor, and review your clinical investigation protocol, and draft your clinical evaluation report.[/vc_column_text][/vc_column][vc_column width=”1/2″][vc_empty_space height=”50px”][vc_column_text]We connect and facilitate partnerships for our clients. The successful launch of a clinical trial is made possible with the deployment of principal investigators and well-prepared documentation to the IRB.

We mitigate client risk in clinical trials by evaluating the market potential and suitability of clients’ products and assess if the necessary requirements have been met. Our team of engineers can offer objective opinions on the industrial design for prototyping purposes.[/vc_column_text][/vc_column][/vc_row][vc_row css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652435067681{padding-top: 30px !important;padding-bottom: 30px !important;}”][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=”CLINICAL TRIALS TODAY” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]Clinical trials are increasingly required for commercialization of medical equipment. This process can be complicated.

What can be even more challenging is the high costs of a clinical trial, along with the difficulty in finding principal investigators (PI) and subjects for the trial. Global and local clinical research organizations (CROs) are there, but they can be costly and have underwhelming results too.

Institutional review boards (IRBs) must approve a clinical trial’s documented protocol and local clinical sites before any clinical study begins. Collaboration with local hospitals is required for foreign MedTech SMEs to conduct clinical trials, usability studies, and feasibility studies on local patients. Poorly documented protocols and other underlying reasons are among the many roadblocks to clinical trial start.

However, clinical trial infrastructure is maturing in the Asia-Pacific and it can offer:

  • Potentially lower cost
  • Access to high growth markets
  • Good Clinical Practice (GCP) -Compliant Hospital sites

[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”Our Current Partnerships with Government Hospitals” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]Access-2-Healthcare has established unique collaborations with local hospitals, and this is necessary to enable MedTech SMEs from other countries to perform clinical investigation and trials, usability studies, feasibility trials on local intended patients.

The profile of hospitals that we are partnering with are:

  • Large government hospitals with clinical innovation units and GCP-compliant clinical investigation support
  • Connection with top academic universities (usually the School of Medicine of the university)
  • Clinical Ethics Review Board, Principal Investigators, and site management
  • Usability lab for summative evaluation of Medical Device Usability.

Access-2-Healthcare has signed agreements with 2 government hospitals that are highly reputable in Malaysia and Thailand (both 1500+ beds). With their GCP-compliant processes and facilities, along with a large pool of PIs and multicultural trial subjects at an affordable price, it becomes an attractive solution to your clinical trial needs.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”Strategic Plan” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]The strategic plan Is for Access-2-Healthcare to have up to 5 clinical sites in 5 countries to support medical device SMEs and start-ups

Current – Malaysia, Thailand

Planned – Japan, China, Australia or Taiwan, or Korea[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”What Our Partner Government Hospitals Provide” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]Hospitals, as clinical research centers, will propose their solutions (site management, sourcing of principal investigators, patient subjects, clinical facilities, etc.) and charges their fees independently from Access-2-Healthcare (authorised representation, support before and after clinical trial, investment referral, clinical design reviews, etc.). This ensures transparency and avoids unnecessary costs.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”What Access-2-Healthcare Provides” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]Access-2-Healthcare offers a solution because we have the local office that you would require to be your clinical trial local authorized representative.

Note that these are countries in which we have in-country representation, which means we can support your clinical studies adequately. We can also provide an expert review of clinical investigation protocols

Authorised representation facilitates the following:

  • Communication with regulatory authorities – clinical study communication, post-market clinical follow-up (PMCF), adverse event reporting
  • Support for importation of trial or demonstration medical devices, medical device storage options
  • Specific communication with the hospital staff, principal investigators and research staff

[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”Supporting Innovation Management and Clinical Advances” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]We mitigate client risk in clinical trials by evaluating the market potential and suitability of clients’ products, assessing if the necessary requirements have been met. Our team of engineers can offer objective opinions on the industrial design for prototyping purposes.

We understand the various challenges faced by the companies preparing for clinical trials because we have the experience to consult and support companies in the earlier stages of development. We can become your clinical site sponsor and review your clinical investigation protocol to achieve your objectives.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”Case Studies” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]There are 2 ways of cooperation between a government hospital and a foreign manufacturer

  1. Research study, if the medical device is very innovative with great impact to healthcare
  2. Fee-for-service, for regulatory, or marketing purposes

Here are several cases studies (anonymised) that A2HC have supported:

Software as medical device (neurology, dental)

Retrospective study – Support of company in Singapore in looking for diagnostic images to improve existing algorithms for regulatory purposes (clinical evaluation). Hospital clinical research center connected to facilities with these images, as well as the principal investigators, and connected to the University for collection.

Demonstration/user trial – Support company from Korea to allow related specialists and surgeons to try and evaluate the software. Access-2-Healthcare went through the hospital clinical research center, who sourced for the specialists and surgeons. If the users are satisfied with the performance, can proceed on with the regulatory approvals for commercial sales.

In-vitro diagnostics

Sample collection – Support of company in Korea to collect urine samples to evaluate various cancers in various stages for their test kit’s clinical and performance evaluation. Access-2-Healthcare went through the hospital clinical research center, who sourced for the specialists and surgeons. Discussed on number of samples, and protocol options such as sample transport or analyser import.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”Further Value to Stakeholders” font_container=”tag:h3|font_size:24px|text_align:center|color:%23000080|line_height:36px” use_theme_fonts=”yes”][vc_separator color=”custom” border_width=”2″ el_width=”10″ accent_color=”#ff6600″][vc_column_text]As part of the partnership, Access-2-Healthcare also provides existing medical device clients of the government hospitals various solutions before and after the clinical study, to enable the hospital to acquire the project.

Prior to the clinical study. Access-2-Healthcare can resolve various potential problems of the client (medical device company) related to the design and development, quality compliance, design for manufacturing. These are key requirements for medical devices to be used for clinical studies.

Sometimes clients or the investors of the clients have concerns with the commercial viability of the medical device. Access-2-Healthcare provides necessary solutions after clinical study is completed.

Access-2-Healthcare can also provide support for the expansion of manufacturing capabilities, supplier controls, due diligence of critical suppliers and strategic partners.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652437472070{margin-right: 12% !important;margin-left: 12% !important;background-color: #dddddd !important;}”][vc_column][vc_custom_heading text=”What sets us apart” font_container=”tag:h2|text_align:center|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]

WE HAVE EXPERIENCE

We understand the various challenges faced by the companies preparing for clinical trials, because we have the experience to consult and support companies in the earlier stages of development. We are able to look into your clinical site sponsor, and review your clinical investigation protocol, to achieve the ultimate aim.[/vc_column_text][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1646536506323{background-color: #dddddd !important;}”][vc_column][vc_custom_heading text=”What sets us apart: Government Hospitals Partnership” font_container=”tag:h4|font_size:32|text_align:center|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]

The numbers in patients, data, principal investigators, connectivity with universities makes these hospital ideal clinical sites. Access-2-Healthcare had manged to partner with these government hospitals in completing the hospital’s clinical solutions for the MedTech company. As the partnership is strictly collaborative, it simplifies the roles and responsibilities of each stake holder in the clinical trial.

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If you are a MedTech startup, and lack funding for the clinical study, perhaps our investment referral model may suit? Learn more

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And if the trials are successful, why not consider continuing with regulatory approval and sell your product commercially? Learn more

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Research to Development Mentorship

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Investment Referral

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Medical Technology Design & Development

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Quality Systems Consulting

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Clinical site support

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Manufacturing scale up and set up

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Supplier Control Support

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Go-To-Market Strategy Services

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Full Suite Regulatory Services

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Business Due Diligence

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Licensing holding

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Regional Sales / Tech Service Hub

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