Clinical Studies/Perfomance Testing
Clinical Study Design, Management, Analysis, Reports
In whatever market(s) you desire to sell your medical device or IVD (e.g., U.S., Europe, Canada, Australia, etc.), you may need to run a human clinical study to support claims of safety and/or effectiveness in a market application. You may wish to conduct a simpler pilot study to evaluate the viability of a product or to determine under what conditions it is most effective. In other instances, you may wish to perform a clinical trial for research purposes alone. In every market (e.g., U.S., Europe, Canada, Australia, etc.), regulations contain provisions for performing experiments using human subjects and for distributing medical devices that are not yet approved, cleared, licensed, etc. for human clinical study purposes.
Regulatory Insight has designed, managed and analyzed the results of scores of clinical studies for a wide variety of medical devices and IVDs for many different indications and purposes. Although we can’t guarantee the outcome of your study due to various unknowns about the performance of your particular product, we can assure you that your study will be stringently designed to meet both the goals of the research and all applicable regulatory requirements, wherever in the world you wish to run your study.
Regulatory Insight offers the full scope of clinical study services which can be taken as a complete package or from which individual components can be selected, as needed to fit your company’s specific needs. Regulatory Insight can…
Design, develop and write your clinical study protocol, informed consent forms and case report forms.
Identify the suitable organization (e.g., U.S. Institutional Review Board, European Ethics Committee, Canadian Research Ethics Board, etc.), and attain approval from them, for your company and the study principal investigators to perform the human clinical study in the applicable region.
Recruit, train, and provide ongoing support for study principal investigators.
Manage and monitor study progression to assure compliance to the protocol, and regulatory requirements.
Assist in identifying and assuring correct and timely reporting of all adverse events.
Perform remote and/or on-site audits of clinical study compliance.
Design the study database, perform data entry and statistical analysis, and interpret study outcomes.
Compile final clinical study report and prepare the study outcome results to support a submission for regulatory approval.
IRB and IDE Approvals
Any clinical study performed in the United States that involves human subjects is required to have U.S. institutional review board (IRB) approval prior to initiating the clinical study. This involves approval of the clinical study protocol, informed consent form and related materials, and all study principal investigators. Furthermore, a clinical study performed in the United States using an investigational device that has not been approved or cleared by the FDA for the intended application may also require an investigational device exemption (IDE) from the FDA prior to the study’s initiation, such as if the clinical study involves a significant risk device or application.
Regulatory Insight has extensive experience attaining IRB approval for numerous and varied studies and their principal investigators. We can work with your local IRB, such as one affiliated with a particular university where the research will take place, or if you are not affiliated with a local IRB, we can recommend and work with either a suitable local or national IRB.
Regulatory Insight can help you to determine whether your study is a significant risk or non-significant risk study. In the case of a non-significant risk study, we can formulate the strategy to submit the non-significant risk application for your study to the IRB.
In the case of a significant risk device, we can attain both IRB and FDA IDE approval for the clinical study protocol and principal investigators simultaneously to save your company cost and time.
Q-Sub / Pre-Sub
The U.S. Food and Drug Administration is perhaps the most stringent regulatory body when it comes to accepting clinical data in support of a medical device or IVD submission. That’s the bad news. The good news is that if you meet FDA’s rigorous criteria for clinical study design, your data can most likely be used to support your submissions to other regulatory bodies around the world.
Running a clinical study requires a huge investment of time, effort and cost, and finding out that FDA has rejected your company’s 510(k) or PMA application because they found fault with the clinical study design can be devastating. Therefore, FDA offers companies the option of submitting their clinical study protocols to the FDA for a pre-submission review. While it is not a guarantee, companies who do submit their clinical study protocols to FDA for a Pre-Sub review and subsequently adequately address the review issues greatly increase the likelihood that the data from the clinical study submitted in the device application will meet FDA’s criteria, assuming the study outcome is successful, of course.
Regulatory Insight has extensive experience writing and submitting Pre-Subs to the FDA. In fact, we almost always insist on submitting a Pre-Sub for our clients’ study protocols, especially for novel devices or indications for use. We simply believe that without the benefit of a Pre-Sub review, the heightened potential risk of FDA finding fault with the study design after the fact is too great to advise our subjects otherwise. We know precisely what questions to ask during the Pre-Sub process to assure that all the bases are covered. Following the Pre-Sub review, we will work with the FDA in making any necessary modifications to the clinical study protocol to assure that each of the issues raised through the review is satisfactorily addressed
EU and Canadian MDR Requirements
In Europe, clinical studies are regulated by the Medical Device Regulations (Regulation (EU) 2017/745).
In Canada, clinical studies are regulated by the Medical Devices Regulations (SOR/98-282).
Regulatory Insight has experience in establishing human clinical studies in these regions and can assist your company to run your studies in Europe and Canada, including attaining European Ethics Committee approval (for studies run in Europe) and Canadian Research Ethics Board approval (for studies run in Canada).
Often when applying for over-the-counter (OTC) versus prescription indications for use for a device, a usability study is required. A usability study is intended to determine whether a lay person (i.e., the end user of the device) can safely and effectively use the device following the instructions for use without the aid of a medical professional. The usability study may be part of a human clinical study or it may be its own study, when a clinical study is not required, but the company wishes to obtain OTC approval or clearance for a current prescription device. Usability studies are also often useful during the design and development phase of a product.
Regulatory Insight has designed, executed and analyzed the outcome of numerous usability studies to successfully support regulatory submissions for over-the-counter indications for use. We would welcome the opportunity to assist your company in developing a usability study for your device as well.
Virtually all medical devices are required to undergo some number and level of laboratory testing and/or bench testing as part of their regulatory submission process, such as:
Medical electrical safety testing
Electromagnetic compatibility testing
Mechanical stress testing
and many others
Regulatory Insight can assist in determining the precise testing that is required to support your submission. Through our alliances with numerous facilities, we can then recommend the optimal fit facility for your product testing needs.
In addition to its comprehensive regulatory and quality services, Regulatory Insight offers customized market research services to assist your company through all stages of the product cycle.
Regulatory Insight can …
Perform a usability or feature design study to assist in product design and feature configuration.
Conduct a market feasibility study to pre-test market acceptance of your product and to assist in identifying customer niches.
Perform a competitive analysis to assist with market positioning and promotion and estimation of market share potential.
Assist in identification of appropriate distributors/customers for your product.
Conduct customer satisfaction and loyalty/retention surveys.