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.