Pilot pivotal ON MEDICAL DEVICES in Eastern Europe Bulgaria

At Convex clinical research center we conduct 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 your study is designed to meet all pre- and post-market approval requirements. In order to demonstrate the safety and efficacy of your product our team offers the following services for the implementation of clinical trial:

 

CRO/Clinical Operating Services

 

Therapeutic Expertise

 

  • Designing and writing the protocol
  • Registering the trial in applicable database
  • Sample size  
  • Preparation of essential documentation
  • Preparation and maintenance of Trial Master File
  • Investigational product labelling
  • Preparation of import documentation
  • Depot and distribution services
  • Designing e-CRF/ paper-based
  • Preparation of submission package
  • Regulatory and ethical approvals
  • Designing e-CRF/ paper-based
  • Training according to ISO14155/study specific trainings
  • Investigator meeting organization
  • Preparation of a patient recruitment plan and retention strategy
  • Clinical trial coordination and monitoring
  • Full project management
  • Safety reporting
  • Data management and statistical analysis
  • Writing of final report
  • Dental Medicine
  • Dermatology
  • Wound Care
  • Cardiovascular
  • Peripheral Vascular
  • Neurovascular
  • Orthopedic
  • Gastrointerstinal
  • Urological
  • Urogynecological
  • Women’s Health 

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 that there are unexpected sources of bias and confounders that require adjustments to the clinical trial strategy, rigorous studies can be developed using innovative or alternative methods. 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
  • Primary outcome measures that are objective, validated and clinically relevant

Most commonly, the motivation for conduct 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. However, carefully conceived clinical research also has a role in enhancing product development and marketing for non-significant risk products, despite most devices and diagnostics reaching the market after only safety and performance testing in animal models and in vitro. 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 claim. 

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 and gather information on design features that may be modified to optimize proper use of the device. Before designing a pivotal clinical trials to evaluate device safety and effectiveness, pilot studies allow the sponsor to collect data on a series of patient outcomes that may be related to device performance, thereby contributing to the identification and selection of clinically significant measures for use as effectiveness endpoint in a subsequent pivotal trial. Frequently, the selection of measures of safety and effectiveness requires the development of validated assessment methods. More extensive pilot studies can incorporate validation of assessment tools and be used to generate enough data on the interpatient variability of endpoints to support sample size calculation for use in a hypothesis testing study. 

Pivotal trials of safety and effectiveness. A single, well-controlled clinical trial of device performance remains sufficient for RA approvals of a SR 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 or options, effectiveness of new device is expected to be not worse than that of other available device or treatment. With rare exceptions, pivotal trials are multicentered. 

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 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. 

Post marketing Studies. 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 result 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, additional data in support of broader label claims. Post-approval studies may be undertaken as an extension of a pivotal trial via protocol Careful consideration with RA 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 sponsored initiated or required by a RA in response to a perceived safety concern. RA can require companies to conduct post-market surveillance studies for Class II and Class III devices under the following conditions: 

  • The failure of the device would be reasonably likely to result in serious health concerns.
  • The device is intended for implantation in the human body for a period greater than 1 year. 
  • 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