There are a lot of resources for dealing with slow enrolling studies, but what about challenges with studies that enroll very quickly? Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution.

This webinar will address:

  • Differences between bunionectomy and abdominoplasty models
  • The importance of rater and site training
  • Considerations for data collection and analysis

Featured Speakers

Becky Baggett

Senior Project Manager
Rho

Becky Baggett has over 11 years of clinical trial experience managing Phase 1-3 trials.  Most recently, she worked closely with study sites on a large Phase 3 pain trial to complete enrollment 6 weeks early.  She has experience in data management which fosters a clear understanding of the link between clinical and biometrics activities. 

Marina Acosta Enslen

Clinical Team Lead
Rho

Marina Acosta Enslen has 19 years of experience across Phase 1-4 studies. She has held positions in training, clinical monitoring, site level study coordination, clinical study management, site start-up, and data management. Marina has managed regional and global clinical teams on complex trials in multiple indications. As a clinical team leader, she leads site identification and selection; management of the clinical team, development of site and monitor training tools, and clinical monitoring plans.

Ben Vaughn

Principal Statistical Scientist
Rho

Ben Vaughn has participated in over 25 regulatory submissions and is an expert on CDISC standards. His work has included serving as lead statistician to complete displays and datasets for ISS/ISEs and coproducing the ISS/ISE for multiple products, including six NDAs reviewed by DAAAP. He has authored responses to FDA queries regarding NDAs, PMAs, IDEs, and SPAs. He has represented sponsors in FDA meetings. In the past three years, he has supported five sponsors at DAAAP FDA advisory committee meetings.

NOW AVAILABLE ON-DEMAND

Register now for this webinar