CLINICAL TRIALS TODAY
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
Our Current Partnerships with Government Hospitals
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.
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
What Our Partner Government Hospitals Provide
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.
What Access-2-Healthcare Provides
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
Supporting Innovation Management and Clinical Advances
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.
There are 2 ways of cooperation between a government hospital and a foreign manufacturer
- Research study, if the medical device is very innovative with great impact to healthcare
- 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.
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.
Further Value to Stakeholders
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.
- Go to market strategy to understand market potential
- Regulatory Approvals to gain market entry, authorised representation to mitigate business risk of long lead time for regulatory approvals, and due diligence of distribution partners.
What sets us apart
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.