SERVICES
We accelerate the access of new medical devices products to the market by making confident clinical investigation planning, selecting customized solutions and taking strategy decisions for the proper and timely conduct of the medical device investigation. Single center investigation on medical device is one of the right choice.
At Convex clinical research center, we conduct single center clinical investigations on medical devices with due compliance to the pertinent regulation as well as to ISO14155. Our deep understanding of European regulatory agencies ensures any investigation is designed to meet all pre-and post-market approval requirements.
The variety of experts and KOLs working within our organization can support any single center investigation on medical device starting from investigation protocol development throughout finalization of an investigation report. Our database of suitable participants allows us to fit within given enrollment timelines and facilitate the entire process.
Our scope of work covers all services required for the excellent performance of a medical device class I, II and III single center investigation. We aim to transparently demonstrate the safety and efficacy of a medical device under investigation and aim to speed up the entire process by offering complete package of services.
Years of experience
ISO14155 Compliance
Single center excellence
Class I, II & III devices
Well-controlled clinical trials on medical devices have become the standard in the industry for the premarket evaluation of new products and systematic evaluations of performance for products already on the market. The basic principles of good clinical study design developed for trials of pharmaceuticals provide the best foundation for the design of a prospective, analytical study of a medical device.
A successful clinical investigation requires careful planning to clearly delineate a testable hypothesis and to select a study design that can support the required analysis, a suitable control group, and primary outcome measures that are objective, validated and clinically relevant.
Most commonly, the motivation for conducting a clinical study is to demonstrate the safety and effectiveness of an investigational device before marketing, a requirement for registration of implants and other significant risk devices in most international markets. The goal of the clinical study is to confirm, validate, or supplement data from bench and/or animal testing.
Clinical studies are commonly performed to support novel design, new technology and/or new indications for use. Post marketing studies can yield information on safety, enhance product design, extend labeling claims, and provide data on comparative effectiveness and support for cost-benefit claims.
Pilot studies, or feasibility studies are usual single center studies of a limited number of patients designed to accomplish any number of objectives within a clinical testing program. Pilot studies are not usually designed as hypothesis testing studies. Rather, they are intended to generate data in support of the design of rigorous analytical trials.
The first study of a novel investigational device in humans is usually a small pilot study undertaken to evaluate safety under carefully controlled conditions and to provide data supporting broader performance testing in a larger population. Pilot studies are the first opportunity to evaluate the role of the user in device performance under actual clinical conditions.
A single, well-controlled clinical trial of device performance remains sufficient for regulatory approvals of a significant risk device. These prospective, analytical studies provide objective evidence of effectiveness based on single or multiple clinical outcomes of significance.
In combination with data from bench testing and animal studies, results from a single trial are adequate to establish reasonable evidence of safety and effectiveness. When direct comparisons are made to alternative treatment options, effectiveness of new device is expected to be not worse than that of other available device or treatment.
Clinical research conducted on an investigational device before marketing creates the foundation for claims that will appear on its label once marketing authorization is accomplished. This is a critical phase where the expectations for reliable data in support of all aspects of the label are the most rigorous.
For this reason, the clinical portion of the product development plan should never be considered in isolation from the ultimate marketing goal. In some cases, bench testing and animal studies can provide additional performance data to augment the clinical research and support expanded label claims.
Two categories of post-marketing studies can be distinguished: mandated post-approval studies and post-marketing surveillance studies. These studies are usually narrow in scope and focus on generating additional data to expand on results of the pivotal trials in support of product approval.
The objectives of post-approval studies, whether mandated by a regulatory agency or the state of the science, typically include longer-term follow-up and additional data in support of broader label claims. Careful consideration with regulatory agencies in the design of investigational plans before initiation of pivotal clinical trials will likely minimize the need for mandatory post-approval studies.
Distinct from post-approval studies are the various types of post-marketing studies undertaken by a manufacturer to accomplish a variety of goals. These studies may be sponsor initiated or required by a regulatory agency in response to a perceived safety concern.
Regulatory agencies can require companies to conduct post-market surveillance studies for Class II and Class III devices under specific conditions: when the failure of the device would be reasonably likely to result in serious health concerns, when the device is intended for implantation in the human body for a period greater than 1 year, or when the device is a life-sustaining or life-supporting product that is used outside a device user facility.
For more information, please contact us at: info@convex.bg
