For Immediate Release: Contact: October 27, 2014 Mary Kuramoto +1 513-579-9911 X 2523 m.kuramoto@medpace.com Medpace to Present Webinar- Understanding Real World Evidence: A Registry Study Perspective Cincinnati, OH. (October 27, 2014) – Medpace will present a live webinar on Thursday, November 13 titled: Understanding Real World Evidence: A Registry Study Perspective. While randomized controlled clinical trials (RCTs) remain the gold standard for assessing the safety and efficacy of pharmaceutical medicines, there is a growing need to generate real-world evidence (RWE) data, adding value and differentiation to the product profile. This session will outline various types of observational research, addressing main RWE benefits and challenges. Learn how to harness real world evidence incorporating early planning for observational studies. The session addresses best practices for planning and managing a registry, including protocol design, study start-up, site management and data analysis required to reach its objectives. SPEAKERS: Dr. Alexander Artyomenko — Director, Late Phase Clinical Operations, Medpace Dr. Alexander Artyomenko is the Director, Late Phase Clinical Operations at Medpace. Dr. Artyomenko is a cardiologist and has over 12 years of experience in Late Phase clinical research. His unique background encompasses both medical practice and clinical research and development, with a highly successful record in planning and executing global Phase IIIb-IV studies in a variety of therapeutic areas. Dr. Artyomenko has spearheaded Medpace's risk-based monitoring initiatives, bringing together the medical, regulatory, operational, and technology teams to deliver on the promises of RBM. Derenda Nichols — Director of Clinical Trial Management, Medpace Derenda Nichols is the Director of Clinical Trial Management. Derenda Nichols has more than 24 years of experience in the CRO industry, including 13 years in postmarketing and peri-approval research. Derenda has successfully participated in planning and execution of large, multi-country projects, leading both domestic and global teams in a variety of therapeutics including orphan/rare diseases, infectious diseases, cardiovascular, gastroenterology, pediatric populations and women's health. Her late phase research experience includes Phase IIIb/IV, Expanded Access/Named Patient Programs, Large Simple Safety Studies (LSSS), Patient Reported Outcomes, Post-marketing Safety, Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans (RMPs), as well as disease, product, and pregnancy registries. To register go to: http://www.fiercepharma.com/offer/medpacenov2014?source=medpace ### ABOUT MEDPACE Medpace is a global full-service clinical research organization (CRO) providing Phase I-IV core development services for drug, biologic, and device programs. Medpace has strong experience supporting development programs across a number of therapeutic areas including oncology, cardiovascular, metabolic/diabetes, infectious disease, neuroscience, regenerative medicine, and gastroenterology. With extensive medical expertise, and a renowned regulatory affairs department, Medpace employs over 2000 employees and has clinical trial experience in over 45 countries and 6 regions in the US, Europe, Central and Eastern Europe, India, Asia Pacific, and China. From feasibility, research site compatibility, safety, and logistics, Medpace brings efficiencies and operational excellence to both drug and device development programs. In addition, Medpace offers integrated imaging, central and bioanalytical lab capabilities, and clinical pharmacology through wholly-owned business units to provide cohesive, streamlined, and standardized trial management. Learn more about Medpace at www.medpace.com.
© Copyright 2024