Efficient site activation is critical to set the tone for a successful clinical trial. Given the number of activities that are involved during site activation, there are several challenges that are faced -- many of which are encountered time and time again. Therefore, knowing what these challenges are, being able to work through them and even being able to prevent them when possible, is imperative to timely site activation.

This session reviews the processes and reports currently utilized to manage site activation issues, as well as practical tools and lessons learned. The speaker shares firsthand experiences and explains how to implement best practices that address the classic challenges of this dynamic process, while avoiding the pitfalls.

This audio conference covers:

• Understanding clinical site activation challenges
• Processes and reports to help manage the challenges
• Identifying best practices
• Utilizing best practices to avoid encountering classic challenges

About the speaker:

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 has more than eight years of experience working in an FDA-regulated environment, and has been with Covance for six years.

Heather's therapeutic experience includes cardiology, endocrinology and infectious disease (AIDS), oncology (non-small cell lung carcinoma, multiple myeloma), CNS and rheumatoid arthritis. She 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.

Who should attend?

• Clinical Operations Managers
• Site Start-up Staff
• Project Management
• R&D Managers
• Outsourcing Managers

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