Rambam provides high-quality, comprehensive clinical trial services for assessing the efficacy and safety of novel medical devices. The medical device category covers the entire spectrum of non-drug products for the healthcare sector, including devices for diagnosing, treating, imaging, and surgery; disposable medical items and accessories; digital applications to be used by the medical staff and/or patients, etc.
Rambam’s Clinical Trials Unit has extensive experience conducting Phase One, Two and Three clinical trials on innovative medical devices. It routinely assesses devices for use in a large range of medical fields, including cardiology, oncology, neurology, orthopedics, OB/GYN, gastroenterology and many others.
The Clinical Trials Unit offers a broad range of services that include protocol planning, biomedical engineering approval, feasibility verification, consultation with Rambam’s Ethics Committee, contract negotiation and budgeting. The medical devices are tested according to stringent standards and the Unit’s professional staff works closely with the product’s developers throughout the process.
These trials frequently entail proof-of-concept and first-in-humans studies. In addition to recruiting high-quality volunteers, the Unit’s staff connects the device’s developers with the most suitable research partners at Rambam.