Donawa Lifescience Consulting (DLC) has extensive experience across a broad range of therapeutic areas, device classes and study types, as illustrated in the charts below.
Italy - UK - USA
CRO Services
Medical Device Therapeutic Areas
Over the last ten years, one of DLC’s principal areas of expertise has been cardiovascular device studies with 33 projects representing approximately 29% of the total. Other important areas of activity of the clinical group include oncology (11 projects), neurology (11 projects) and musculoskeletal/orthopedics disease (9 projects).
Additional therapeutic areas where DL has developed strong experience include dentistry (6 projects), gastroenterology (5 projects), urology and gynecology (4 projects) as well as ophthalmology, dermatology, hematology, and reconstructive/aesthetic surgery.
In total, DLC has conducted 113 clinical/performance studies, of which around 50% involved high risk (Class III) devices and 65% were pre-market, demonstrating our ability to support clients in the most challenging stages of clinical development involving both pilot and pivotal studies.
DLC also has substantial expertise in performance evaluation studies for in vitro diagnostic (IVD) devices, with 20 projects completed and others ongoing. Several of these were designed to obtain U.S. Food and Drug Administration (FDA) clearance through the 510(k) or de novo pathways. Please visit the dedicated IVD webpage for further information.
Number of Studies by Therapeutic Area
Number of Studies by Device Class
Number of Studies by Study Stage
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