PRA Experts to Present at DIA Annual Conference

Recruitment and Minimal Risk Research Strategies

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Jun 20, 2012, 09:00 ET

RALEIGH, N.C., June 20, 2012 /PRNewswire/ -- PRA, a leading Clinical Research Organization, announces that two of our experts will speak at the DIA 48th Annual Meeting being held in Philadelphia from 24-28 June.

On 25 June at 3:30PM EDT, Gretchen Goller, Senior Director of PRA's Patient Access and Recruitment Services (PARS) group will deliver a speech titled "Setting Sites Up for Success in the New Digital Environment." Her discussion will focus on key elements of success for establishing and supporting clinical trial sites in today's digital world.

Ms. Goller joined PRA in 2011 and has over 15 years of clinical research experience. She began her career as a study coordinator and then became a site director at the University of Pennsylvania. Most recently, Ms. Goller served as a patient recruitment and retention strategist at a pharmaceutical company, where her focus was on Phase II-IV clinical studies. At PRA, Ms. Goller has assumed a leadership role in the PARS group and works with our strategists to implement recruitment and retention programs on all pertinent studies.

On 26 June at 1:30PM EDT, Kathleen Mandziuk, Senior Scientific Affairs Director of PRA's Late Phase Service (LPS) group, will co-lead an interactive session titled, "Non-interventional Minimal Risk Research: A 360-degree Perspective." The discussion will focus on minimal risk research strategies and feature perspectives from a range of industry experts. Specifically, Ms. Mandziuk will focus on the impact of observational/non-interventional research on sponsors, CROs, physicians and patients. Other presenters include Linda Coleman, Director of Regulatory Affairs and General Counsel at Quorum IRB and Winifred Meeker-O'Connell from the Department of Health and Human Services at the FDA.

Ms. Mandziuk has extensive experience in strategic design and implementation of observational and late phase studies and has directed all operational aspects of these projects. In her current role, she is responsible for providing consulting services and developing observational, minimal risk and post-marketing scientific and operational strategies. Throughout her career, Ms. Mandziuk has managed the data aspects of several global post-approval projects from the planning stages through analysis.

PRA's LPS group supports global and regional post-approval studies with management locations centralized in PRA's Horsham, Pennsylvania and Mannheim, Germany offices. This highly experienced team assists clients with the post-marketing process by planning and conducting safety-surveillance studies, large simple trials, disease/product registries, restricted access programs, risk management programs, and diagnostic and biomarker research.

PRA provides comprehensive patient recruitment and retention services to our customers through our internal PARS unit and our strategic partner network. The PARS team has established preferred partnerships with industry-leading, cutting-edge patient recruitment and retention organizations. PRA and our partners provide clients with customized, innovative strategies to raise study awareness, support study sites and drive enrollment.

About PRA

PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.

We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.

To learn more about PRA, please visit praintl.com, email [email protected] or call our Global Headquarters.

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