Bringing Focused Ultrasound Treatment Options to Patients
Clients: Focused Ultrasound Foundation and a European-based Device Manufacturer
Project Overview: KAI supports the Focused Ultrasound Foundation (FUSF) on a wide variety of general clinical research programs and projects and is currently working with the FUSF and clinical research investigators based in several countries to develop an international registry to manage data from pancreatic cancer patients undergoing focused ultrasound treatment. We helped create a set of core and disease-specific data elements that can be added, tracked, and reused in future trials, and KAI will assist with deploying and managing the registry at more than 10 global sites.
We also developed and implemented a safety monitoring program for a European-based manufacturer of focused ultrasound devices to successfully track and report all activities to regulatory authorities for device review, authorization, and approval. Because of this work, patients can now choose a non-invasive treatment for benign tumors, avoiding potential complications of surgery.
Results: Our expertise in advancing science in a complex stakeholder and regulatory environment is helping to efficiently bring to patients safe and innovative new therapeutic technologies that improve outcomes and save lives.