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:
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:
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.
Please contact us for more information on our European clinical trial management services for medical devices.
Ask us for detailed information about Europe clinical evaluation report services.
Learn about the process, costs and timelines.
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