The Covance team is uniquely qualified to provide skilled consulting and guidance at every stage of the REMS process. With a combined 30 years of risk management experience, our senior experts have worked on more than 20 REMS projects across a broad range of therapeutic areas.
Edgar Adams, ScD, Executive Director – Epidemiology
Dr. Adams provides scientific oversight of REMS programs, with more than 15 years of experience consulting on the design, assessment, and implementation of REMS, RiskMAPs, and observational studies.
Jessica Brainerd, MPH, Program Manager
Ms. Brainerd works with clients to develop, implement, operate, and evaluate REMS programs and has a thorough understanding of REMS submissions to the FDA.
Jennifer Breen, Program Manager
Ms. Breen provides operational oversight of the multiple components of REMS programs, primarily those with Elements to Assure Safe Use, including risk management and mitigation, contact center management, as well as compliance monitoring and follow up.
Shoshana Daniel, PhD, Statistician
Dr. Daniel provides statistical expertise in the development of proposed REMS and REMS supporting documents, as well as the assessment and evaluation of REMS programs (including developing survey protocols, surveys, and REMS assessment reports).
Anjali Hinduja, Director
Ms. Hinduja has participated and managed a number of complex transitions and REMS systems implementations including the design of a multi-lingual global restricted acess and registry website.