WHAT: A new drug application (NDA) covers information about a product from inception through clinical trials, thus making it imperative for sponsor and contract research organizations to present the FDA with a coherent and clear integration of data from product development programs.
Rho, a full-service contract research organization (CRO), will provide valuable insight and important considerations for developing the integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) sections of an NDA submission through a free webinar.
WHO: Ben Vaughn, senior statistical scientist, Rho
Rob Woolson, statistical scientist, Rho
WHEN: Tuesday, February 11, 2014
1:00 p.m. ET/ 10 a.m. PT
Webinar Registration: Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
DETAILS: For media inquiries, please contact Jessica Highsmith at Largemouth Communications, (919) 459-6456, jessica@largemouthpr.com.
ABOUT: Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 25 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. For more information, please visit www.rhoworld.com and follow us on Twitter.
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