From study design to feasibility assessment to patient enrollment, many important considerations factor into achieving timely completion of renal/hepatic impairment studies. As traditional renal and hepatic impairment studies have shifted, efficiently conducting these studies to understand the effect of a treatment and achieve regulatory approval requires a comprehensive, cross-functional strategy.
Join this webinar to hear from four specialists in the field as they share their insights for optimizing a clinical development plan, identifying key protocol parameters, best practices for managing the medical and scientific aspects of impairment studies and how to choose the right sites and perform start-up quickly. They will also cover practical considerations for handling the complexity of Phase I studies, conducting a “reduced PK study” per the FDA guidance and working with dialysis cohorts.
Register today and expand your knowledge about improving efficiencies in your renal and hepatic impairment programs.
Jane Royalty, MD, Senior Medical Director, Global Early Clinical Development, Covance
Dr. Jane Royalty is an Internal Medicine Physician, ABIM Board-Certified, with 20 years of experience in clinical research and internal medicine. She has broad therapeutic area expertise in early phase protocol design and development including FIH through early patient trials, for small and large molecules, and all submission supporting studies. She also supports the oversight of special population clinical trials, including renal and hepatic impairment populations.Message Presenter
Thomas C. Marbury, MD, President, Orlando Clinical Research Center
Dr. Thomas Marbury has served as Principal Investigator in over 1,000 Clinical Trials since 1978. He has published extensively in scientific and clinical journals and is regarded as a thought leader in the area of renal and hepatic trials. He has presented on various panels with other clinical pharmacology experts and FDA leaders at the industry’s national meetings. He is the founder and President of Orlando Clinical Research Center since 1990. As the President of Orlando Clinical Research Center, his main areas of research are Phase I clinical trials.Message Presenter
Jackie Miller-Giles, MS, Senior Clinical Scientist, Global Early Clinical Development, Covance
Jackie Miller-Giles has over six years of experience in fundamental research and laboratory science and over 14 years of clinical research experience focusing on early phase and clinical pharmacology protocols across a wide range of therapeutic areas. She has supported extensive renal and hepatic impairment trial design and protocol development.Message Presenter
Jasmine Ropers, Senior Project Manager, Covance Clinical Pharmacology Services
Jasmine Ropers has 20 years of industry experience. She began her career in Data Management and transitioned over to Project Management twelve years ago. She has been overseeing renal and hepatic impairment trials for 11 years and is the impairment study operational subject matter expert at Covance.Message Presenter
Who Should Attend?
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Clinical Operations
- Commercial and Sales
- Chief Medical Officer
- Clinical Development Manager
What You Will Learn
In this webinar, participants will learn:
- How to optimize your clinical development plan for impairment assessment
- Insights on the protocol development and eligibility enrollment processes
- Streamlining feasibility assessment to achieve a fast startup
- How to conduct a “reduced PK study” and tips for working with dialysis cohorts
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.