Clinical Trial Management for Medical Devices in Europe
Are you planning to conduct clinical trial in Europe? Then your key to success is to have all the necessary information needed at hand. Do you need help to recruite good sites and surgeon’s? Do you need to know what ethics committee and competent authority approvals you will require? Bielderman’s extensive experience and practical knowledge can help you set up a suitable study design to ensure that you get the right answer to your questions and meet the right objectives.
Bielderman’s clinical division (based in Belgium) has expertise and experience setting up, conducting and reporting clinical trials designed for:
- Demonstrating the clinical safety and effectiveness of a medical device for CE Marking;
- Obtaining health economic data to support obtaining reimbursement approvals.
- Obtaining post-market surveillance clinical data on devices with CE Marking;
With appropriate study endpoints in mind Bielderman will design your clinical trial. We will develop your clinical study and help you to determine the optimal number of patients and study sites, study duration and length of follow-up. Whether you need to collect data to support CE Marking, a scientific publication, or drive marketing awareness/acceptance you can count on Bielderman. Our clinical division offers comprehensive clinical trial management services covering everything from study design and protocol preparation to management of the study, data analysis and final reporting. Members of our clinical consulting team speak English, Dutch, German, Italian, South-African and French.
The clinical division offers a comprehensive clinical trial service. A full list of Bielderman’s clinical services is given below:
- surgeon / centre recruitment;
- identification of qualified independent third parties to conduct radiographic data analysis [Core lab facilities];
- study design input / review – optimisation of endpoints and scoring systems;
- facilitate study patient insurance
- preparation of monitoring outcome reports;
- preparation / review of study documentation (i.e. protocol, clinical investigation brochure, case report forms, patient information letters, informed consent forms
- Competent Authority and Ethics Committee submission and liaison;
- data collation and input into database;
- database design and validation;
- data analysis to generate interim and final reports
- case support to facilitate implant of novel implants according manufacturers specifications
- study monitoring (initiation visits, routine intra-study visits and close-out visits);
- data queries handling;
- traceability to hard copy patient records and identification of duplicate entries;
- final report and study masterfile compilation; and,
- project management of the clinical study
At Bielderman, our medical device clinical trial management Department, covers every aspect of devices even those with a focus on high risk products including cardiovascular and orthopedic implants. Prospective CE Marking and post-marketing surveillance clinical studies has been conducted 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.