Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference provides insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

This audio conference covers how to:

• Capitalize on the expertise and experience of your CRO partner
• Capture key ideas regarding project risk analysis and discover where it may go wrong
• Establish effective communication infrastructures to keep projects on time and on budget
• Understand and gain insights to the Safety Factor
• Identify metrics and milestones for continuous improvement

About the speakers:

Yvonne Albright is a Project Manager at Covance Periapproval Services. Her current responsibilities include management of a CAD-device study, the first study of its kind for Periapproval. In addition to her wide range of experience in managing and monitoring in the cardiovascular therapeutic area (venous thromboembolism), she has experience in Health Economics, Chronic Pain (osteoarthritis) and Women’s Health (osteoporosis, fibromyalgia and secondary menorrhea). Yvonne received a Master of Science Degree in Nursing from Widener University School of Nursing. She is a member of Sigma Theta Tau International Nursing Honor Society and currently holds certification as Clinical Research Associate through ACRP.

Barbara Vargas is a Senior Project Manager at Covance Periapproval Services. Since joining Covance in 1997, she has worked in both safety surveillance and clinical operations, holding many positions with increasing responsibility. Barbara has accumulated extensive experience managing and monitoring Phase II, IIIb and IV studies in several therapeutic areas in drug, device, and observational programs within hematology/oncology, infectious disease, asthma, depression, pain, transplants, cerebrovascular and ophthalmology. She received a BSN from La Salle University in Philadelphia, Pennsylvania where she graduated Magna Cum Laude, and holds a current license as a registered nurse.

Who should attend?

• Project Managers
• Clinical Trial Managers
• Directors of Operations
• Clinical Research Associates
• Clinical Trial Leads

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.