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Airtrust assists medical device companies with clinical trial strategy and assist in protocol design review, study management, data management, clinical trial monitoring, biostatical analysis, and report preparation to ensure that clinical data is collected appropriately to effectively support any necessary SFDA submissions in China.

As medical technology continues to advance and product development becomes more complex, outsourcing to medical services can offer a number of strategic benefits. By avoiding the need to hire additional in-house staff or purchase costly data management software, and by leveraging Airtrust's knowledge of regulatory requirements, clients can realize significant cost-savings and often a faster, more efficient path to market.

As a full-service organization focused on the medical device industry, Airtrust is uniquely able to support you through all phases of clinical development and testing. Our process allows us to be involved in the assisting in design, management, and monitoring medical device studies, representing varied technologies and therapeutic areas.

Working with your team, we will help you to design and implement a clinical trial that will best meet your business needs, whether you need clinical data to support a regulatory pre-market submission, drive product adoption, support product reimbursement, or monitor post-market product use.

Airtrust will begin the design of your clinical trial with the formulation of appropriate study endpoints. Whether you need to collect data to support a pre-market submission, a scientific publication, or drive physician adoption and market acceptance, these endpoints will support the content of your study and help you to determine the appropriate number of patients and study sites, study duration and length of follow-up.

Additionally, the appropriate clinical trial strategy is dependent on where you plan to commercialize your medical device. China medical device requirements for clinical data can differ significantly from U.S. FDA requirements, so it is important to consider all these factors early in the development of your medical device clinical trial.

In general, to support China SFDA requirement, you must demonstrate that your device is safe, that it performs as intended, and that the level of risk is acceptable when weighed against the benefits. Within the CHINA Medical Device Directives, the term "clinical data" encompasses everything from bench testing to clinical trials in human subjects. While some devices do require conduct of a specifically designed clinical investigation, it is often possible, for low- to medium-risk devices (Class I, IIa, and IIb), to prepare a compilation of relevant scientific literature to support the device's intended use and the techniques employed. If the products have both CE Mark and FDA approval, then, the process is much more easily compared to no approval cases.

The Chinese clearance / approval process for medical devices is very different from the European CE marking process, as well as from FDA process, especially in terms of the scope and size of clinical trials required for high-risk devices.

To market a device in the EU, you must demonstrate that the device is safe and that it performs in a manner consistent with the intended use. To market a class III high-risk (and some class II) device in the United States, you must demonstrate that the device is reasonably safe and effective. To market a class III high-risk device in China, you have to combine both CE process and FDA process and follow a SFDA procedure to demonstrate the product safety. This typically requires a prospective, randomized controlled, adequately powered clinical trial involving a few to hundreds of patients.

Working with your team, we will help you design a clinical study to meet your needs and identify the best data measurements to support your product claims. Our experienced clinical services professionals will advise you on how to best measure the effectiveness of your product, in the most clinically meaningful and cost-effective way possible.

After your medical device clinical trial strategy is developed and your study endpoints are in place, Airtrust will assist you with a full range of study initiation services. Airtrust will oversee day-to-day study activities, giving you confidence that all of the relevant data is captured, collected, and interpreted to support your study goals. Our project manager will work with you to:

Identify and qualify the best study sites and investigators for your medical device
Conduct pre-study qualification visits to assess your sites
Prepare your team and support you during initial meetings with the SFDA, Test Institutes, hospitals, medical institutes and other regulatory bodies to introduce your medical device and negotiate your pre-clinical trial and clinical trial test plans
Assist in prepare your study materials, including an appropriate study protocol, Case Report Forms, and informed consent documents
Prepare any necessary documentation for SFDA Ethics Committee approval
Conduct pre-investigational visits to train the clinical trial site staff on the protocol, study materials, applicable regulations and Good Clinical Practices for your medical device

You will receive routine reporting and communication as your study progresses to keep you apprised of data accrual and data quality on a site-by-site basis, and to keep you and your study team on track.

Chinese SFDA regulations require that a clinical trial sponsor monitor the progress of a clinical investigation to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data submitted to the SFDA.

Similarly, the International Conference on Harmonization (ICH), which was organized to develop tripartite harmonization initiatives with input from the European Union, Japan, and the United States, states that the purposes of clinical trial monitoring are to verify that the rights and well-being of human subjects are protected, to verify that the reported clinical trial data are accurate, complete, and verifiable from source documents, and to verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practices and with the applicable regulatory requirement(s).

Airtrust regularly monitors medical device clinical trials on a daily basis in China. Our clinical research associates will ensure that your study is performed in accordance with SFDA regulations and ICH guidelines and:

Ensure investigator compliance with the protocol and regulations and identify any deviations to the clinical study plan
Verify subject eligibility and informed consent
Ensure reporting of adverse events
Review and verify study data
Identify and resolve any problems at the study sites during the course of your clinical trial
Prepare study sites and sponsors for SFDA inspections that may occur during the course of your clinical study or after the study is closed.

The quality of a medical device clinical study is ultimately dependent on the integrity of the data collected during the clinical trial. Appropriate, well-organized data are critical to the success of your clinical study. Using documented, repeatable processes, Airtrust will provide your data faster, without compromising quality. Airtrust's staff handles all your data collected throughout your clinical trial. Our data management services feature:

As a final step in the clinical trial process, you will need to prepare a comprehensive clinical study report to support your regulatory submission, product registrations, reimbursement strategy, or other research and development needs and marketing objectives.

Working in collaboration with you and your clinical investigators, Airtrust will prepare a final clinical report to summarize study design, patient assessment, demographic data, data analysis and results, medical device failures and replacements, risk/benefit analysis, device safety and effectives, and other issues that will best communicate the results of your trial and support your study objectives.