The CRO Group’s corporate U.S. headquarters is strategically located in suburban Boston, Massachusetts, and within a short train/taxi ride of three major medical, dental and biomedical engineering schools: Harvard, Boston University, and Tufts, and the well known research and teaching hospitals which these schools serve. As such, CRO Group partners have access to specialists in virtually all fields of medicine and dentistry and can recruit seasoned principal investigators familiar with IRB and FDA as well as international investigational regulations with a no-repeat required approach to getting the trials and reports completed and fully supportive of your submission process.
With partners and affiliates located on both coasts in the USA, Canada, and Europe, we are in the unique position of offering multi-site investigation planning, management, and compliance services to support your 510(k), PMA, and EU Design Dossier or Technical File.
Setting up a trial in the USA and expecting it to be “useable” for CE Marking/European registration is not necessarily a given. That is why The CRO Group is a leader in clinical study design, protocol development, recruiting Principal Investigators, securing IRB /IEC approval, CRA/trial conduct management, case report assessment, preparing reports, and compliance monitoring and auditing for your global multi-center trials supporting device registrations, advertising claims and or capturing the all important government reimbursement.