Clinical Investigations
Are you preparing to undertake a clinical investigation in Europe?
Do you want to go on to use the data collected in support of a FDA application?
Do you need help with surgeon or site recruitment?
Do you know what ethics committee and competent authority approvals you will require?
Our clinical division has expertise and experience in the setting up, conduct and reporting of clinical studies designed for:
− demonstrating the clinical safety and effectiveness of a device for CE Marking and / or FDA submissions;
− obtaining post-market surveillance clinical data on CE Marked devices; and,
− obtaining health economic data to support obtaining reimbursement approvals.
We will design your clinical trial with the formulation of appropriate study endpoints in mind. Whether you need to collect data to support CE marking, a scientific publication, or drive marketing awareness and market acceptance, Emergo UK Ltd. will devise your study and help you to determine the optimal number of patients and study sites, study duration and length of follow-up.
The clinical division offers a comprehensive clinical trial service, covering everything from study design and protocol preparation to management of the study, data analysis and final reporting. Our clinical consultants have English, Dutch, German and French language capabilities.
Our clinical division offers a comprehensive range of services including but not limited to:
• surgeon / centre recruitment;
• study design input / review – optimisation of endpoints and scoring systems;
• identification of qualified independent third parties to conduct radiographic data analysis;
• preparation / review of study documentation (i.e. protocol, clinical investigation brochure, case report forms, patient information letters, informed consent forms, etc.);
• Competent Authority and Ethics Committee submission and liaison;
• database design and validation;
• arrangement of patient insurance;
• study monitoring (initiation visits, routine intra-study visits and close-out visits);
• preparation of monitoring outcome reports;
• data collation and input into database;
• data queries handling;
• data analysis and manipulation;
• traceability to hard copy patient records and identification of duplicate entries;
• final report and study masterfile compilation; and,
• project management of the clinical study
Our clinical expertise and experience covers a range of devices, with the focus on high risk devices such as cardiovascular and orthopaedic implants. We have conducted prospective CE Marking and post-marketing surveillance clinical studies on drug / device combinations, including drug-coated cardiovascular implants and antibiotic impregnated dressings, both of which have provided valuable insight into the ethics committee and competent authority requirements for clinical studies involving drug / device combinations.
