ICON has provided project management / monitoring services for more than 48 Women’s Health trials with pharmaceutical compounds and medical devices. These trials involved over:
Central to our women’s health solution is our Women’s Health team which is comprised of women’s health experts that represent the coalescence of therapeutic, medical, scientific, product development and life cycle management expertise within ICON. Coupled with our Women’s Health Project Management professionals they deliver scientific, operational and therapeutic expertise that spans the development continuum from concept through development to post-approval activities--a truly integrated, full-service solution.
ICON understands the unique requirements of medical device development. With more than 600 device clinical trials and over 1200 consulting engagements, our medical device team has unmatched expertise. Our medical device experts include regulatory professionals, quality auditors, clinical project managers, clinical monitors, data managers, and biostatisticians who offer a wealth of U.S. FDA, EU, and global experience.
In the last 5 years ICON has provided regulatory consulting and clinical support in more than 15 women’s health medical device studies in area such as Meshes, Urethral Support Systems, Pubourethral Sling, Sutures, Culdoscope and accessories, Cryopreservation, diagnostic systems.