News & Events CTI To Present at FDA Public Workshop

CTI To Present at FDA Public Workshop

April 11, 2017

CTI Clinical Trial & Consulting Services To Present at FDA Public Workshop

FOR IMMEDIATE RELEASE [Cincinnati, OH ~ April 11, 2017]

CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service contract research organization will present at the FDA Public Workshop: Antibody Mediated Rejection in Kidney Transplantation, taking place April 12-13, 2017. William Irish, MSc, PhD, will speak on the topic "How to Perform Clinical Studies in Low Incidence Disease/Condition - Collaborative Clinical Studies, Pros and Cons of Composite Endpoints."

This Food and Drug Administration (FDA) public workshop is intended to provide information for and gain perspective from individuals, industry, health care professionals, researchers, public health organizations, patients, patient care providers, and other interested persons on various aspects of clinical development of medical products for prophylaxis and/or treatment of AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will also help in developing topics for future discussion.

"I am honored to be a part of this public workshop on behalf of the FDA," according to Dr. Irish. "CTI is a leader in this field, with contributions to nearly all transplant-related therapies on the market today."

Dr. William Irish is currently Vice President, Biostatistics and Health Outcomes Research, with over 30 years of academic and industry experience. He works in outcomes research, statistical modeling and prediction, risk assessment, competing risk analysis, clinical trial methodology, and large-scale database and claims analysis. In addition to his role at CTI, Dr. Irish is also Adjunct Assistant Consulting Professor in Transplant Surgery for Duke University. He also serves as Associate Editor for Clinical Transplantation. Prior to CTI, he held various positions with RTI International, SangStat Medical Corporation, and the University of Pittsburgh. He received his PhD in epidemiology from the University of Pittsburgh and his MSc in statistics from Queen’s University.

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com

Media Contact

Allison Schroeder - CTI | 513.598.9290 | aschroeder@ctifacts.com

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