Efficient site activation is critical to set the stage for clinical trial success. Given the number of activities that is involved during site activation several challenges are faced, many seemingly time and time again. It is imperative to timely site activation to know what these classic challenges are, being able to work through them and even being able to prevent them when possible.

During this double presentation, the speakers will share their experiences specializing in site activation, and the best practices that have been implemented to handle the classic challenges of this dynamic process. This perspective will be given from the site management organization and CRO viewpoints. There will be an in-depth, interactive discussion of the classic challenges, touching on why they occur.  Examples of processes and reports currently utilized to manage these issues will be presented, along with practical tools and lessons learned that will address the prevention of the pitfalls and more efficient site activation.

SPEAKERS:

Heather Almonte, BS, MBA, Senior Manager, Site Activation Services, Clinical Development Services, Covance
Mrs. Heather Almonte is a Site Activation Services Senior Manager at Covance in Princeton, NJ. Her current responsibilities include the project management of logistical study aspects including: site selection support, regulatory document collection/review, budget and contract negotiations, regulatory document maintenance and investigator payments. She serves as the primary liaison between Site Activation Services and the operational project teams and is responsible for assuring timelines are met, status and metrics reporting and staffing. In addition to these responsibilities she provides training and is a resource regarding regulatory and logistical study aspects.

Heather received her BS in Pharmacology/Toxicology from the University of the Sciences in Philadelphia, an MBA from Drexel University, and a Certificate in Regulatory Affairs from San Diego State University.

Kathy S. Cox, MS,  President & CEO, Interspond LLC
Kathy S. Cox, MS obtained her BSE from the University of Wisconsin - Whitewater in 1984 and her MS from the University of Wisconsin - LaCrosse in 1989. She has worked in the pharmaceutical research industry since 1989. She founded one of the original TMOs back in 1996. Since then she has continued to develop and fine tune this business model and has built it into what it is today. Interspond continues to thrive under her leadership and her thorough knowledge of this industry. Ms. Cox prides herself on Interspond's stellar reputation and the repeat business Interspond has enjoyed over the years.