Rho, Inc.

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Clinical regulatory support Our clinical regulatory experts can serve as resources to create protocols that can be finalized quickly and supported by sites so that studies run on time or even ahead of schedule. We provide investigational new drug (IND) and new drug application (NDA) support and guide the client through each step of the process: providing expert advice, planning meetings, preparing pre-meeting briefing packages, and facilitating communication with regulatory agencies.

Dr. Shoemaker has 25 years of experience in pharmaceutical development and has led the regulatory strategy for programs in many therapeutic areas. He has experience with all types of regulatory submissions and has moderated dozens of FDA meetings. Key Tips for Developing Orphan Products Dr. Shoemaker offers six essential tips for developing orphan products based on his extensive experience working with products intended to treat rare and orphan diseases.

Rho's experience advances Phase II and Phase III trial management Rho is adept at managing every aspect of Phase II and Phase III trials. We offer a broad range of services that allows us to provide capacity and experience in clinical trial management. Clinical operations provides experience and leadership at each site The value of Rho's Clinical Operations lies in the experience we bring to the client. As a result, we can provide strong site management and enrollment strategies.

Ben Vaughn Senior Statistical Scientist, Rho Ben Vaughn has twelve years of experience in clinical research. He has participated in nearly 20 regulatory submissions, coproduced the ISE for two opioid products; and provided statistical consultation, display generation and submission work for four separate products for OA knee pain. Last spring he attended an FDA advisory committee to represent the sponsor for an opioid product. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs.

Our statisticians have vast experience with common safety endpoints and can tackle the challenges of integrated analyses (ISS and ISE) for numerous therapeutic areas. We provide documentation of statistical methods and results that will impress even the most skeptical of FDA reviewers.

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