At FCE Source, we are often asked the question: “what does a Field Clinical Engineer do?” Many within the medical device industry are still learning the value of adding FCEs to a trial. In discussions with potential clients (who later hired us) we’ve been told “we think...
Successful clinical trials balance scientific rigor with ease of executability. Trials designed with the best intentions of collecting as much evidence as possible are often (ironically) the ones generating the least useful data because they are too difficult to execute. Clinical trial design must take into account the time and effort required from subjects (patients), coordinators, and investigators. Protocols achieve this through what we refer to as Design for Executability (DFE).
The transition of a clinical study from a written document into real-world medical research carried out by separate yet synchronized teams of Investigators and Coordinators across the country is an incredible feat. The training required for each clinical site is immense, as Investigators and Coordinators learn the novel technology as well as the specifics of screening, enrollment, and data management. To effectively implement a clinical study, sponsor companies should provide Investigators and Coordinators with study aids and tools as supplementary resources to the protocol.