Clinical Trial Management for Medical Devices in Europe

Are you preparing to undertake a clinical trial in Europe? 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 based in the UK has expertise setting up, conducting and reporting clinical trials designed for:

• Demonstrating the clinical safety and effectiveness of a medical device for CE Marking.
• Obtaining post-market surveillance clinical data on devices with CE Marking.
• Obtaining health economic data to support obtaining reimbursement approvals.

Pepgra will design your clinical trial with appropriate study endpoints in mind. Whether you need to collect data to support CE Marking, a scientific publication, or drive marketing awareness/acceptance, 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.

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 and French.

Our EU clinical trial management division offers a comprehensive range of services including:

• Surgeon / center recruitment.
• Study design input / review - optimization 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 database input.
• Data queries handling, analysis and manipulation.
• Traceability to hard copy patient records and identification of duplicate entries.
• Final report and study masterfile compilation
• Project management of the clinical study.

Our medical device clinical trial management expertise covers a range of devices, with a focus on high risk products including cardiovascular and orthopedic 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.