News
March 16, 2009
MDCI Staff to Present at Association of Clinical Research Professionals (ACRP) Global Conference
Susan Rockwell, associate director of clinical development and Jacqueline Barrows, clinical trials manager, will present multiple sessions at the 2009 ACRP Annual Meeting, focusing on ways to ensure the conduct of effective and successful medical device clinical trials.
On Friday, April 24, Ms. Barrows, and Bert Verheyen, manager of field clinical operations at Medtronic Europe will co-present an interactive workshop entitled, "High Impact Techniques for Managing a Home-Based CRA Team". The performance of clinical research associates, responsible for monitoring the activities of medical device clinical trials, contributes directly to the trial's ultimate success. Very often CRAs are located remotely, which can present unique challenges to clinical trial managers. Ms. Barrows and Mr. Verheyen will discuss and demonstrate proven tools and techniques to boost CRA monitoring performance, including the development, formulation, and practical use of quantitative monitoring objectives, targeted coaching, and enhanced communication methods. Differences between field clinical operations in the U.S. and Europe will also be addressed.
On Monday April 27, Ms. Rockwell, along with Joseph Giorgianni, director of clinical affairs at Stryker Spine, will present, "Are You Ready for a Sponsor BIMO Inspection - Experiences from a Medical Device Sponsor and CRO's Mock FDA Inspection". This session will focus on how to best prepare for an inspection by FDA's Bioresearch Monitoring Division (BIMO), which conducts inspections of medical device clinical trial sponsors as a key step in the FDA medical device pre-approval process. Ms. Rockwell and Mr. Giorganni will share experiences in conducting an unannounced, mock FDA BIMO inspection, and provide recommendations on developing and implementing effective internal processes to ensure a successful inspection outcome.
On Tuesday, April 28, Ms. Rockwell and Kate Giovino, director of clinical operations at Organogenesis, Inc. will jointly present "Bioresearch Monitoring in Medical Devices: Practical Considerations When Preparing for and Responding to FDA Inspections". This session will present an overview of the FDA BIMO inspection program, current FDA statistics on commonly reported site and sponsor deficiencies, and real-life examples of PMA medical device study inspections. The session will also include a discussion of recent trends in compliance rates for medical device clinical investigators and medical device study sponsors.
For additional detail and registration information, visit http://www.acrp2009.org.
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