Changes in the US and EU medical device regulatory climate mean market access and approval is more dependent than ever on the collection of prospective clinical data. In an effort to try and reduce the time to market, companies may be tempted to rush through clinical trial design without seeking collaborative input from medical, regulatory and clinical operations experts. Such decisions can lead to significant delays in trial initiation/execution as well as an increase in costs which translates to lost market opportunity.
In this webinar, we explore four areas that can dramatically affect the cost and timelines of your clinical program and offer insight into elimination and control of these hidden landmines. A cardiovascular device case study will highlight these key points:
- Trial Design – The importance of maintaining sight of programmatic goals to avoid a “bloated” program
- Medical Writing – Seeking early strategic input on how data will be presented in the clinical study report
- Data management/biometrics– Bringing these “back-end” services forward as active participants in program development
- Site Selection – Maximizing use of historical site metrics to optimize selection and staging of site activation
Sheryl Helsinger BS, Director, Clinical Trial Management, Medpace
Sheryl Helsinger has more than 25 years’ experience in global clinical research, including 15 years in the medical device industry. She has a strong research and development background, experience with Rx to OTC switch products, and open/laparoscopic surgical device products (Trocars, staplers, harmonic scalpels, etc.). Prior to joining Medpace she led the Clinical Operations organization for a large medical device company in Cincinnati Ohio. Ms. Helsinger has a research background, starting her career as a bench scientist before leading Clinical Trials for products such as Aleve and Prilosec. This diverse experience gives her a unique perspective on clinical protocol development and execution of the clinical program.
Courtney Busemeyer, MEd. Sr. Director, Data Management at Medpace
Courtney Busemeyer has more than 15 years of data management experience at Medpace. Over the course of her career, she has managed both pharmaceutical and medical device trials in all phases of clinical development in key therapeutic areas including oncology, cardiovascular, endocrine, metabolic, and rare disease. In her current role at Medpace, she is responsible for the secure and accurate collection and cleansing of clinical trial data. She has been working in EDC since 2007 and is the business owner of Medpace’s propriety data management system, ClinTrak® EDC. Courtney has a Bachelors in Mathematics from the University of Cincinnati and a Master’s in Education from Xavier University.
Celeste A. Morris, PhD, RAC. Medical Writer, Regulatory Affairs at Medpace
As a Medical Writer at Medpace, Celeste A. Morris works directly with Sponsor companies to write clinical study protocols, reports, and regulatory documents for the FDA. Prior to joining Medpace, she worked in academics both as a college professor at Northern Kentucky University and as a Research Assistant at a number of different academic institutions including Peking University, Beijing, China. Her medical device experience includes development of rapid-analysis sensors for emergency medicine applications, devices for electrochemical analysis of hormones, and combination products to improve drug delivery mechanisms at the nanoscale. Celeste received her PhD in Analytical and Materials Chemistry from Indiana University, Bloomington, IN and her Bachelors of Science in Chemistry from Northern Kentucky University.
Who Should Attend?
VPs, Directors, Managers and Department Heads working within:
- Clinical Research
- Regulatory Affairs
- Medical Writing
- Clinical Data Management
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its physician-led, high-science, and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,500 people across 35 countries.