Activity

  • mjf34 replied to the topic CROs in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

    Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investigators and overall managing/checking investigators. The reason why I selected these was because most of the other work that a sponsor is responsible for can usually be learned very quickly, such as record keeping, filing IDE’s/safety reports, maintaining a quality system, manufacturing/ storing/ packaging/ labeling product, and creating the financial disclosure. However, selecting monitors/investigators and managing them is a task that requires more interpersonal skills, and ultimately needs to be someone that you can trust to do the job right. Outsourcing this task to a CRO could result in the sponsor and investigator or monitor not getting along or not meeting expectations.